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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06107413 | Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab | PHASE2 | ACTIVE NOT_RECRUITING | 280 | — | — | Nov 12, 2023 | Dec 1, 2026 | Dec 12, 2025 | 64 | United States, Belgium +6 |
OR is defined as complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator.
PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
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.
| Arm | Type | Description |
|---|---|---|
| Stage 1: ABBV-400+FFB A | EXPERIMENTAL | Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration. |
| Stage 1: ABBV-400+FFB B | EXPERIMENTAL | Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration. |
| Stage 2: ABBV-400+FFB A Low | EXPERIMENTAL | Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration. |
| Stage 2: ABBV-400+FFB A High | EXPERIMENTAL | Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration. |
| Stage 2: FFB+Irinotecan (Standard of Care [SOC]) | EXPERIMENTAL | Participants will receive SOC during the 3 year study duration. |
| Stage 3: ABBV-400+FFB B Low | EXPERIMENTAL | Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization/expansion, during the 3 year study duration. |
| Stage 3: ABBV-400+Bevacizumab C High | EXPERIMENTAL | Participants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-400 | DRUG | Intravenous (IV) Infusion |
| Bevacizumab | DRUG | IV Infusion |
| Folinic Acid | DRUG | IV Infusion |
| Fluorouracil | DRUG | IV Infusion |
| Irinotecan | DRUG | IV Infusion |
Inclusion Criteria: * Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC). * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Progressed on only one first-line (1L) systemic treatment of combination chemotherapy...