Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Trial number:
NCT05425940
Trial phase:
3
Study type:
Immunotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

September, 2022

Scientific title

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Summary

The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Key

* Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.

* Documented rat sarcoma (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 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 participant 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 Response Evaluation Criteria in Solid Tumors (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 (common terminology criteria for adverse events \[CTCAE\] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Adequate organ and marrow function. * Fertile participants 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. * Females of childbearing potential must not be pregnant at screening.

Key

Study design

Primary purpose: TREATMENT, Allocation: RANDOMIZED, Intervention model: PARALLEL, Masking: NONE,

Conditions

Colorectal Cancer

Other study ID numbers

2021-003243-21; XL092-303

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