Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed after or are intolerant to standard-of-care (SOC) therapy.
- Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or
- 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
- 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 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.
- 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.
Join this Trial
- TRIO-US - Jonesboro AR
- TRIO-US - Orlando FL
- TRIO-US - Redondo Beach
- TRIO-US - Sylmar
- TRIO-US - Whittier
- UCLA Alhambra
- UCLA Beverly Hills
- UCLA Burbank
- UCLA Irvine
- UCLA Laguna Hills
- UCLA Pasadena
- UCLA Porter Ranch
- UCLA San Luis Obispo
- UCLA Santa Barbara
- UCLA Santa Monica
- UCLA Valencia
- UCLA Ventura
- UCLA Westlake Village