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
Phase 1
- Conditions
- Colorectal CancerMedDRA version: 21.0Level: PTClassification code: 10061451Term: Colorectal cancer Class: 100000004864MedDRA version: 21.0Level: LLTClassification code: 10052362Term: Metastatic colorectal cancer Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10052358Term: Colorectal cancer metastatic Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505110-14-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 206
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.
Exclusion Criteria
Harbor the BRAF V600E mutation., dMMR+/MSI-H., Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy., Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method