Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07525206 | A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer | PHASE3 | NOT YET_RECRUITING | 700 | — | — | May 7, 2026 | May 1, 2029 | Apr 13, 2026 | - | — |
| NCT07023289 | A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease | PHASE2 | RECRUITING | 140 | — | — | Sep 2, 2025 | Nov 1, 2029 | Jun 2, 2026 | 47 | United States, Belgium +6 |
| NCT06464692 | Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 31 | — | — | Sep 30, 2024 | Dec 1, 2027 | May 11, 2026 | 8 | China |
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.
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.
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 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. |
| 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 |
| Standard of Care | DRUG | Standard of care treatment based on investigator's judgement to the active surveillance. |
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...