Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
- Trial number:
- NCT05425940
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
Has received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
Systemic SOC anticancer therapy if approved and available in the country where the subject is randomized.Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen. Measurable disease according to RECIST v1.1 as determined by the Investigator. Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization. Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. Age 18 years or older on the day of consent. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Adequate organ and marrow function. Fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment. Female subjects of childbearing potential must not be pregnant at screening.