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

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with MSS/MSI-low mCRC who have progressed after or are intolerant to standard-of-care (SOC) therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exelixis
• Collaborator: Roche Pharma AG
• Treatments: Atezolizumab

Criteria

Inclusion Criteria:

• 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.

• Radiographic progression during treatment with or within 3 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 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.

Exclusion Criteria:

• Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).

• Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.

• Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.

• Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.

• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.

• Concomitant anticoagulation with oral anticoagulants and platelet inhibitors.

• Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.

• Pregnant or lactating females.

• Administration of a live, attenuated vaccine within 30 days before randomization.