Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sacituzumab Tirumotecan (SKB264), Sac-TMT, Sacituzumab Tirumotecan (sac-TMT), MK-2870, SKB264, SKB264 MK-2870
Sacituzumab tirumotecan · 25 trials · 44 indications
EFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by blinded independent central review (BICR): residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or death from any cause. The EFS for all participants will be presented.
OS is defined as time from randomization to death due to any cause.
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
OS is defined as the time from randomization to death due to any cause.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
OS is defined as the time from randomization to death due to any cause.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR in participants with programmed cell death ligand 1 (PD-L1) at combined positive score (CPS) ≥1 tumors will be presented.
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
OS is defined as the time from randomization to death due to any cause.
To determine the intracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. RANO-BM evaluates treatment response by categorizing results into Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Assessed by the investigator through imaging follow-up (CT scan/MRI) using Response evaluation criteria in solid tumors (RECIST) version 1.1. This will be considered as the percentage of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
The percentage of patients with confirmed partial response (PR) or complete response (CR) based on RECIST 1.1 criteria where Complete Response (CR) - disappearance of all target lesions and measurable lymph nodes. Partial Response (PR) - ≥30% decrease in the sum of target lesion diameters (SLD) compared to baseline, with no new lesions or progression of non-target lesions. Stable Disease (SD) - change in SLD between -30% and +20% compared to baseline, with no new or unequivocally progressing non-target lesions. Progressive Disease (PD) - ≥20% increase in SLD compared to the smallest recorded SLD (nadir) or appearance of new lesion
DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0.
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.
DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 1 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 1 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study treatment due to an AE in Part 1 will be reported.
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the NCI CTCAE 5.0. The number of participants who experience a DLT in Part 2 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 2 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study treatment due to an AE in Part 2 will be reported.
ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) (disappearance of all target lesions) or partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator. ORR will be reported for participants in Part 2.
A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
A DLT is defined as any of the following: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or lymphopenia; any nonhematologic AE ≥Grade 3 in severity (with some exceptions); any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; a prolonged delay (\>2 weeks) in initiating sacituzumab tirumotecan second dose due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during DLT evaluation period; or any Grade 5 toxicity. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy | EXPERIMENTAL | Participants will receive sac-TMT 4 mg/kg by intravenous (IV) infusion every 2 weeks (q2w) for up to 6 doses plus pembrolizumab and berahyaluronidase alfa 790 mg SC every 6 weeks (q6w) for up to 2 doses. CRT (radiotherapy \[RT\] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine. Pembrolizumab and berahyaluronidase alfa 790 mg SC will be administered q6w for up to additional 7 cycles as consolidation therapy. Each cycle is 42 days (up to approximately 42 weeks). |
| Chemoradiotherapy | EXPERIMENTAL | CRT (radiotherapy \[RT\] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine. |
| Sacituzumab tirumotecan | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity. |
| Chemotherapy | ACTIVE_COMPARATOR | Participants receive paclitaxel 175 mg/m\^2, docetaxel 75 mg/m\^2, or vinflunine 320 mg/m\^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity. |
| Sac-TMT +/- Bevacizumab | EXPERIMENTAL | Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses. |
| Standard of Care | ACTIVE_COMPARATOR | Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab. |
| sac-TMT | EXPERIMENTAL | Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses. |
| Part 1: Sacituzumab tirumotecan + Bevacizumab | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks |
| Part 2: Sacituzumab tirumotecan | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation. |
| Part 2: Standard of care (SOC) | ACTIVE_COMPARATOR | Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation. |
| Arm A: Sacituzumab Tirumotecan | EXPERIMENTAL | Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation. |
| Arm B: Sacituzumab Tirumotecan + Pembrolizumab | EXPERIMENTAL | Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to \~2 years). |
| Arm C: Treatment of Physician's Choice (TPC) | ACTIVE_COMPARATOR | Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m\^2 once every week (Q1W) OR paclitaxel IV 90 mg/m\^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m\^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m\^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation. |
| Treatment of Physician's Choice (TPC) | ACTIVE_COMPARATOR | At the physician's discretion, participants will receive 500 mg/m\^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m\^2 (or 1.25 mg/m\^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m\^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m\^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m\^2 (or 125 mg/m\^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation. |
| Pemetrexed Plus Carboplatin | ACTIVE_COMPARATOR | Participants receive, via IV infusion, 500 mg/m2 pemetrexed every 3 weeks (Days 1 and 22 of every 6-week cycle) plus area under the curve (AUC) 5 mg/mL\*min carboplatin every 3 weeks (Days 1 and 22 of every 6-week cycle for 4 doses), then 500 mg/m2 pemetrexed every 3 weeks until discontinuation criteria is met. |
| Arm B:Pembrolizumab + Sacituzumab tirumotecan | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years). |
| Pembrolizumab + Sacituzumab tirumotecan | EXPERIMENTAL | Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (\~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks). |
| Pembrolizumab | ACTIVE_COMPARATOR | Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks). |
| Cohort 1: papillary renal carcinoma (pRCC) | EXPERIMENTAL | Patients with pRCC will be included in this group. All patients are allocated to same intervention (sacituzumab tirumotecan), regardless of the cohort |
| Cohort 2: variant histology urothelial carcinoma (VH-UC) | EXPERIMENTAL | Patients with VH-UC will be included in this group. All patients are allocated to same intervention (sacituzumab tirumotecan), regardless of the cohort |
| Phase 2: Treatment with Sacituzumab Tirumotecan | EXPERIMENTAL | Treatment with sacituzumab tirumotecan will occur until clinical or radiographic progression,unacceptable toxicity, withdrawal of consent for study participation. |
| Single Arm | EXPERIMENTAL | Treatment with Sacituzumab Tirumotecan |
| Ramucirumab + Paclitaxel | ACTIVE_COMPARATOR | Participants receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to \~60 weeks plus paclitaxel at 80 mg/M\^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) until discontinuation. |
| Sacituzumab Tirumotecan + Paclitaxel | EXPERIMENTAL | Following a 28-day run-in with sacituzumab tirumotecan at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants receive paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) plus sacituzumab tirumotecan at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation. |
| HER3-DXd + Ramucirumab | EXPERIMENTAL | Participants receive HER3-DXd via IV infusion on days 1 and 22 of each 6-week cycle plus ramucirumab at 8mg/kg via IV infusion on days 1 and 15 and 29 of each 6-week cycle until discontinuation. |
| Sacituzumab tirumotecan plus EV | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan as an intravenous (IV) infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. |
| Sacituzumab tirumotecan plus EV and pembrolizumab | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan as an IV infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. Participants will also receive pembrolizumab 200 mg as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles). |
| Sacituzumab tirumotecan + Chemotherapy | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. |
| Sacituzumab tirumotecan + Cisplatin + Pembrolizumab | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years. |
| Arm 1: Sacituzumab tirumotecan Monotherapy | EXPERIMENTAL | Participants receive single doses of sacituzumab tirumotecan monotherapy once every 2 weeks (Q2W). |
| Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy | EXPERIMENTAL | Participants receive sacituzumab tirumotecan Q2W in combination with pembrolizumab once every 6 weeks (Q6W). |
| Name | Type | Description |
|---|---|---|
| Sac-TMT | BIOLOGICAL | IV infusion |
| Pembrolizumab and Berahyaluronidase alfa | BIOLOGICAL | Pembrolizumab coformulated with berahyaluronidase alfa administered as a SC injection |
| Cisplatin | DRUG | IV infusion administered at 35 mg/m\^2 weekly for up to 6 doses during RT |
| 5-FU | DRUG | IV infusion administered at 500 mg/m\^2 on Days 1 to 5 and Days 22 to 26 during RT |
| MMC | DRUG | IV infusion administered at 12 mg/m\^2 on Day 1 during RT |
| Capecitabine | DRUG | Oral dose administered at 825 mg/m\^2 twice daily during RT |
| Gemcitabine | DRUG | IV infusion administered at 27 mg/m\^2 twice weekly for up to 12 doses during RT |
| Conventional Radiotherapy | RADIATION | External beam radiation administered per global clinical guidelines (64 Gy at 2 Gy/fraction over approximately 6.5 weeks) |
| Hypofractionated radiotherapy | RADIATION | External beam radiation administered per global clinical guidelines (55 Gy at 2.75 Gy/fraction over approximately 4 weeks) |
| Rescue Medications | DRUG | Participants receive rescue medications at the investigator's discretion, per approved product label. Rescue medications include pegfilgrastim (or equivalent), H1 receptor antagonist, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent), steroid mouthwash (dexamethasone or equivalent). |
| Sacituzumab tirumotecan | BIOLOGICAL | IV infusion |
| Vinflunine | DRUG | IV infusion |
| Docetaxel | DRUG | IV infusion |
| Paclitaxel | DRUG | IV infusion |
| Rescue medications for sacituzumab tirumotecan | DRUG | Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent). |
| Rescue medications for chemotherapy | DRUG | Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative. |
| Bevacizumab | DRUG | Administered via IV infusion at a dose of 15mg/kg |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Rescue Medication | DRUG | Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent). |
| Carboplatin | DRUG | IV infusion |
| Doxorubicin | DRUG | IV infusion |
| Epirubicin | DRUG | IV infusion |
| Cyclophosphamide | DRUG | IV infusion |
| Olaparib | DRUG | Oral tablet |
| H1 receptor antagonist | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| H2 receptor antagonist | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| Acetaminophen (or equivalent) | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| Dexamethasone (or equivalent) | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| Steroid mouthwash (dexamethasone or equivalent) | DRUG | Rescue medication taken orally 2-4 times daily |
| Nab-paclitaxel | DRUG | IV Infusion |
| Pemetrexed | DRUG | IV infusion |
| Tisotumab Vedotin | BIOLOGICAL | IV infusion |
| Topotecan | DRUG | IV infusion |
| Vinorelbine | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Trifluridine-Tipiracil | DRUG | Trifluridine-tipiracil will be administered at 35 mg/m\^2 as tablet orally twice a day on days 1-5 and 8-12 of every 28-day cycle. |
| Supportive care measures | DRUG | Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors. |
| Liposomal doxorubicin | DRUG | IV infusion |
| Sacituzumab Tirumotecan (SKB264) | DRUG | Sacituzumab tirumotecan will be administered by IV infusion on Days 1 of each 2-week cycle. There is a maximum duration of exposure for sacituzumab tirumotecan of 78 doses (approximately 3 years). Treatment may be prematurely terminated in case of disease progression, unacceptable toxicity, consent withdrawal, or physician criteria. |
| Ramucirumab | BIOLOGICAL | 8 mg/kg IV Infusion |
| HER3-DXd | BIOLOGICAL | IV Infusion |
| Enfortumab Vedotin | BIOLOGICAL | IV infusion at different dose levels |
| Fluorouracil (5-FU) | DRUG | 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks. |
| Leucovorin (LV) or levoleucovorin | DRUG | LV or levoleucovorin is administered by IV infusion every 2 weeks. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1) * Has clinically nonmetastatic bladder cancer (N0-N1M0) * Is either ineligible for radical cystectomy or has opted for bladder pre...
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Sacituzumab tirumotecan is an investigational antibody-drug conjugate being developed for the treatment of solid tumors. It is being studied in bladder cancer, breast neoplasms, cervical cancer, colorectal cancer, endometrial cancer, and gastroesophageal cancer. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Sacituzumab tirumotecan targets TROP2, a protein expressed on many tumor cells. As an antibody-drug conjugate, it uses an antibody component to bind TROP2 and deliver a cytotoxic payload to the cancer cell. This targeted approach aims to concentrate the anti-tumor effect on TROP2-expressing cells.
Sacituzumab tirumotecan is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is running multiple clinical trials of the drug across several cancer types, including a Phase 3 study in bladder cancer.
Sacituzumab tirumotecan is in Phase 3 clinical development. The Phase 3 trial is evaluating the drug in combination with pembrolizumab in participants with bladder cancer. Additional Phase 2 trials are planned in penile cancer, genitourinary tumors, and neuroendocrine prostate cancer.
Sacituzumab tirumotecan is being studied in several clinical trials. These include NCT07829783, a Phase 3 trial in bladder cancer; NCT07815197, a Phase 2 trial in penile cancer; NCT07716917, a Phase 2 trial in genitourinary tumors; and NCT07639086, a Phase 2 trial in neuroendocrine prostate cancer. All are currently not yet recruiting.
Yes, sacituzumab tirumotecan is also known as sac-TMT and SKB264. These names refer to the same investigational antibody-drug conjugate. The abbreviation sac-TMT is frequently used in clinical trial titles and scientific literature.