Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Raludotatug Deruxtecan (R-DXd)
Raludotatug Deruxtecan · 4 trials · 5 indications
ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a 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 defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported.
Objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 criteria.
Disease control rate (DCR) is defined as proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (maintained for ≥5 weeks) according to RECIST version 1.1.
DLTs are defined as toxicities during the DLT evaluation period that are assessed by the investigator to be possibly, probably, or definitely related to study treatment and include: Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia lasting ≥7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding; Grade 4 lymphocytopenia lasting ≥14 days; Grade 4 anemia of any duration; any other Grade 4 hematologic toxicity lasting ≥7 days; febrile neutropenia Grade 3 or Grade 4 meeting pre-specifications; pre-specified hepatic organ toxicities; all Grade 3 or higher other nonhematologic toxicities except those pre-specified; other pre-specified nonhematologic toxicities; any delay in treatment with the planned dose of ≥21 days or discontinuation of treatment due to a toxicity during the DLT evaluation period, or Grade 5 toxicity. The number of participants with DLTs will be reported.
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 number of participants with one or more AEs will be reported.
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 number of participants who discontinue study intervention due to an AE will be reported.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Raludotatug Deruxtecan | EXPERIMENTAL | Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met. |
| Ifinatamab Deruxtecan | EXPERIMENTAL | Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met. |
| Docetetaxel | ACTIVE_COMPARATOR | Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met. |
| Raludotatug Deruxtecan (R-DXd) | EXPERIMENTAL | R-DXd will be administered via IV infusion. |
| Endometrial Cancer Cohort | EXPERIMENTAL | Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W). |
| Cervical Cancer Cohort | EXPERIMENTAL | Participants with cervical cancer who will receive R-DXd administered intravenously Q3W. |
| Non-high-grade Serous Ovarian Cancer | EXPERIMENTAL | Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W. |
| Urothelial Cancer Cohort | EXPERIMENTAL | Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W. |
| Clear Cell Renal Carcinoma (ccRCC) Cohort | EXPERIMENTAL | Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W. |
| Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1) | EXPERIMENTAL | Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan (R-DXd) in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation. |
| Cohort A-1 Arm 2 (R-DXd + Paclitaxel) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive R-DXd until disease progression or discontinuation. |
| Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2) | EXPERIMENTAL | Participants receive escalating doses of intravenous (IV) R-DXd in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive R-DXd until disease progression or discontinuation. |
| Cohort B-1 (R-DXd + Bevacizumab) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation. |
| Cohort B-2 (R-DXd RP2D + Bevacizumab) | EXPERIMENTAL | Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV R-DXd in combination with bevacizumab until disease progression or discontinuation. |
| Cohort C-1 (R-DXd + Pembrolizumab) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive R-DXd until disease progression or discontinuation. |
| Cohort D (R-DXd +/- Bevacizumab) | EXPERIMENTAL | Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation. |
| Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab) | EXPERIMENTAL | Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of carboplatin with or without bevacizumab, until disease progression or discontinuation. |
| Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab) | EXPERIMENTAL | Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of paclitaxel with or without bevacizumab, until disease progression or discontinuation. |
| Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab) | ACTIVE_COMPARATOR | Participants with PSROC will receive one of 3 regimens of investigator's choice of platinum-based doublet chemotherapy with or without bevacizumab. Platinum-based doublet chemotherapy will be administered for maximum of 8 cycles. Bevacizumab can be administered until disease progression or discontinuation. |
| Cohort E-1 (R-DXd + MK-2010) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with MK-2010. Participants can receive up to a maximum of thirty-five 3-week cycles of MK-2010 (approximately 2 years) and will receive R-DXd until disease progression or discontinuation. |
| Cohort C-2 Arm 1 (Carboplatin + Paclitaxel + Pembrolizumab → R-DXd + Pembrolizumab) | EXPERIMENTAL | Participants will receive carboplatin (Dose 1 or Dose 2), paclitaxel (five 3-week cycles), and pembrolizumab during the induction phase. During the maintenance phase, participants will receive RP2D of IV R-DXd (up to 2 years; participants with PR or SD at 2 years may continue until disease progression) in combination with pembrolizumab (up to thirty-five 3-week cycles). |
| Cohort C-2 Arm 2 (Carboplatin + Paclitaxel) | EXPERIMENTAL | Participants will receive carboplatin (Dose 1 or Dose 2) and paclitaxel (seven 3-week cycles), followed by standard of care observation. |
| Cohort C-2 Arm 3 (R-DXd + Pembrolizumab + Bevacizumab) | EXPERIMENTAL | Participants with PSROC will receive RP2D of R-DXd in combination with pembrolizumab (up to thirty-five 3-week cycles) and bevacizumab until progressive disease. |
| Name | Type | Description |
|---|---|---|
| Raludotatug Deruxtecan | BIOLOGICAL | IV Infusion |
| Ifinatamab Deruxtecan | BIOLOGICAL | IV Infusion |
| Docetetaxel | DRUG | IV Infusion |
| 5-hydroxytryptamine subtype 3 receptor antagonist | DRUG | Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion |
| Neurokinin-1 receptor antagonist | DRUG | Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion |
| Corticosteroid | DRUG | Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration |
| Raludotatug Deruxtecan (R-DXd) | BIOLOGICAL | Administered via intravenous (IV) infusion. |
| Carboplatin | DRUG | IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles. |
| Paclitaxel | DRUG | IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles. |
| Bevacizumab | BIOLOGICAL | IV infusion on Day 1 of every 3-week cycle. |
| Rescue Medication | DRUG | Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol. |
| Pembrolizumab | BIOLOGICAL | IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles. |
| Gemcitabine | DRUG | IV injection on days 1 and 8 of each 3-week Cycle |
| Pegylated liposomal doxorubicin | DRUG | IV injection administered on Day 1 of each 4-week cycle |
| MK-2010 | DRUG | IV infusion on Day 1 of every 3-week cycle |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC) * Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell dea...
Raludotatug Deruxtecan is an investigational monoclonal antibody being studied for advanced solid tumors, gastrointestinal cancer, carcinoma, non-small-cell lung cancer, and recurrent ovarian cancer. It is in Phase 2 clinical development and is not yet approved by the FDA.
Raludotatug Deruxtecan is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. It is being evaluated across multiple oncology indications, including solid tumors and gastrointestinal cancers.
Raludotatug Deruxtecan is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Raludotatug Deruxtecan is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Multiple trials are ongoing, including a Phase 1 study in ovarian cancer and Phase 2 studies in solid tumors, lung cancer, and gastrointestinal cancers.
Raludotatug Deruxtecan is being studied in several trials: NCT06660654 (Phase 2, advanced solid tumors), NCT06780085 (Phase 2, non-small cell lung cancer), NCT06843447 (Phase 1, recurrent ovarian cancer), and NCT06864169 (Phase 2, gastrointestinal cancers). These trials are active and recruiting or not yet recruiting participants.
Yes, Raludotatug Deruxtecan is also known as R-DXd. This alternative name is used in clinical trial titles and publications, such as the study of R-DXd in people with gastrointestinal cancers (NCT06864169).