Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
About
Brief Summary
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 during, after or are intolerant to standard-of-care (SOC) therapy.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
- 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.
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.
- Subject has uncontrolled, significant intercurrent or recent illness.
- Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
- Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
- History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
- Pregnant or lactating females.
- Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
- Administration of a live, attenuated vaccine within 30 days before randomization.
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Study Stats
Protocol No.
23-000253
Principal Investigator
Contact
Location
- TRIO-US - Jonesboro AR
- TRIO-US - Orlando FL
- TRIO-US - Redondo Beach
- TRIO-US - Sylmar
- TRIO-US - Whittier