Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telisotuzumab Adizutecan · 13 trials · 14 indications
Confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
OS is defined as the time from randomization to the event of death from any cause.
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.
Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.
Percentage of participants with clinically significant ECGs findings as assessed by the investigator.
Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
OS is defined as the time from randomization to the event of death from any cause.
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.
OR is defined as (subjects achieving complete response \[CR\] or partial response \[PR\]) as assessed by ICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (criteria) (RANO) 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1.
PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per BICR based on RECIST version 1.1 or death from any cause, whichever occurs earlier.
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST version 1.1.
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
DLTs are defined as grade \>= 3 thrombocytopenia that cannot clinically improve after adequate medical treatment/support, febrile neutropenia grade \>= 3 or grade 4 neutropenia that cannot clinically improve after adequate medical treatment/support, and any grade 2 or higher interstitial lung disease (ILD)/pneumonitis that cannot clinically improve after adequate medical treatment/support.
Cmax of telisotuzumab adizutecan conjugate.
Tmax of telisotuzumab adizutecan conjugate.
AUC of telisotuzumab adizutecan conjugate.
Total antibody of telisotuzumab adizutecan.
Unconjugated payload of telisotuzumab adizutecan.
| Arm | Type | Description |
|---|---|---|
| Ph 3: Telisotuzumab Adizutecan + Bevacizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration. |
| Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab | EXPERIMENTAL | Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration. |
| Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration. |
| Telisotuzumab Adizutecan Dose B | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration. |
| Telisotuzumab Adizutecan Dose A + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 38 month study duration. |
| Telisotuzumab Adizutecan Dose B + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 38 month study duration. |
| Pembrolizumab + Platinum Chemotherapy + Fluorouracil | ACTIVE_COMPARATOR | Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 38 month study duration. |
| SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period. |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration. |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration. |
| SS1: Dose Optimization: Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration. |
| Ph 2: Dose Escalation Telisotuzumab Adizutecan + FOLFOX | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan + fluorouracil, folinic acid, and oxaliplatin (FOLFOX) until doses for optimization are determined, as part of an approximately 2 year study period. |
| Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose A | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration. |
| Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose B | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration. |
| Ph 2: Dose Optimization Standard of Care (SOC) mFOLFIRINOX | ACTIVE_COMPARATOR | Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
| Ph 3: Telisotuzumab Adizutecan RP3D + FOLFOX | EXPERIMENTAL | Participants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period. |
| Ph 3: SOC mFOLFIRINOX | ACTIVE_COMPARATOR | Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose B | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration. |
| Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration. |
| Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration. |
| Phase 3: Stand of Care (SOC) | EXPERIMENTAL | Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration. |
| Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration. |
| Telisotuzumab Adizutecan Monotherapy | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration. |
| Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants will receive SOC, during the approximately 51 month study duration. |
| Stage 1: Escalation Telisotuzumab Adizutecan + Osimertinib | EXPERIMENTAL | Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration. |
| Stage 1: Expansion Telisotuzumab Adizutecan Dose A + Osi | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration. |
| Stage 1: Expansion Telisotuzumab Adizutecan Dose B + Osi | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration. |
| Stage 1: Expansion Telisotuzumab Adizutecan Dose C + Osi | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration. |
| Stage 1: Expansion Osi + Chemotherapy + Pemetrexed | EXPERIMENTAL | Participants will receive Osi with chemotherapy followed by Osi with pemetrexed, as part of the approximately 76 month study duration. |
| Stage 2: Standared of Care (SOC) | EXPERIMENTAL | Participants will receive SOC, as part of the approximately 76 month study duration. |
| Stage 2: Optimized Telisotuzumab Adizutecan + Osi | EXPERIMENTAL | Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration. |
| Substudy 1: Dose Escalation Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose | EXPERIMENTAL | Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose | EXPERIMENTAL | Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 1: Dose Expansion Compatator | EXPERIMENTAL | Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Escalation Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose | EXPERIMENTAL | Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose | EXPERIMENTAL | Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration. |
| Substudy 2: Dose Expansion Compatator | EXPERIMENTAL | Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration. |
| Stage 1: Dose Escalation ABBV-400 | EXPERIMENTAL | Participants will receive escalating doses of telisotuzumab adizutecan (ABBV-400) in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration. |
| Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan (ABBV-400) dose A in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration. |
| Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan (ABBV-400) dose B in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration. |
| Stage 2 Arm 3: Dose Optimization Standard of Care (SOC) | EXPERIMENTAL | Participants will receive a fixed dose of leucovorin (folinic acid), fluorouracil, oxaliplatin (FOLFOX) and budigalimab as part of the approximately 6 year study duration. |
| Part 1: Telisotuzumab Adizutecan + Budigalimab | EXPERIMENTAL | Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration. |
| Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration. |
| Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab | EXPERIMENTAL | Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration. |
| Part 2: Standard of Care | EXPERIMENTAL | Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration. |
| Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants with unresectable locally advanced/metastatic colorectal cancer (CRC) will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration. |
| Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose B | EXPERIMENTAL | Participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose B during the approximately 2.5 year study duration. |
| Dose Expansion Part 1: Telisotuzumab Adizutecan Dose A | EXPERIMENTAL | Participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration. |
| Dose Expansion Part 2: Telisotuzumab Adizutecan Dose C | EXPERIMENTAL | If further analysis is warranted, participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose C during the approximately 2.5 year study duration. |
| Name | Type | Description |
|---|---|---|
| Telisotuzumab adizutecan | DRUG | Intravenous (IV) |
| Bevacizumab | DRUG | Intravenous (IV) |
| Trifluridine/Tipiracil | DRUG | Oral |
| Pembrolizumab | DRUG | IV |
| Carboplatin | DRUG | IV |
| Cisplatin | DRUG | IV |
| Fluorouracil | DRUG | IV |
| Gemcitabine | DRUG | Intravenous (IV) Infusion |
| Nab-Paclitaxel | DRUG | Intravenous (IV) Infusion |
| Folinic acid/ Leucovorina | DRUG | IV Infusion |
| Oxaliplatin | DRUG | IV Infusion |
| Irinotecan | DRUG | IV Infusion |
| Standard of Care | DRUG | Standard of Care |
| Osimertinib | DRUG | Oral |
| Osimertinib (Osi) | DRUG | Oral |
| Pemetrexed | DRUG | IV |
| Leucovorin | DRUG | IV Infusion; IV Injection |
| Panitumumab | DRUG | IV Infusion |
| Budigalimab | DRUG | IV Infusion |
Inclusion Criteria: * Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator...
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Telisotuzumab Adizutecan is an investigational antibody-drug conjugate being developed for multiple oncology indications, including metastatic colorectal cancer, non-small cell lung cancer, non-squamous non-small cell lung cancer, pancreatobiliary cancers, and solid tumors harboring MET amplification. It is currently in Phase 3 clinical development.
Telisotuzumab Adizutecan is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Telisotuzumab Adizutecan is in Phase 3 clinical development for oncology indications. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in patients.
Telisotuzumab Adizutecan is being studied in several clinical trials, including NCT06464692 for colorectal cancer, NCT06628310 for gastric and esophageal adenocarcinomas, NCT06772623 for non-small cell lung carcinoma, and NCT07023289 for colorectal cancer. These trials are at various phases and are actively enrolling or ongoing.
Yes, Telisotuzumab Adizutecan is also known as ABBV-400. Clinical trials reference both names, with ABBV-400 used in study titles and Telisotuzumab Adizutecan as the drug's nonproprietary name. Both names refer to the same investigational antibody-drug conjugate.