Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer (STELLAR-303)

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

  • Clinical Trial Information

    Trial Contact: Bobe Cortes, Estefania

    Trial Phone: 321.841.6626

  • IRB No: 20223436

    Protocol Abbrev: TRIO-XL092-303

    Principal Investigator: Omar R. Kayaleh, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: TRIO XL092-303

    Treatment: Experimental: Experimental Arm Subjects with mCRC will receive XL092 + atezolizumab Drug: XL092 Supplied as tablets; administered orally daily Drug: Atezolizumab Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once in a 3-week cycle (q3w) Other Name: Tecentriq® Active Comparator: Control Arm Subjects with mCRC will receive active comparator of regorafenib Drug: Regorafenib Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle Other Name: Stivarga® ID: NCT05425940

  • Objective

    The primary objective of this study is to evaluate the efficacy of XL092 + Atezolizumab versus regorafenib in subjects with RAS wild-type MSS/MSI-low mCRC who have progressed after or are intolerant to SOC therapy.

  • Key Eligibility

    Inclusion Criteria:
    •   Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
    o Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
    o 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.
    o 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.