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

Active Not RecruitingPhase 3

Sponsor: Exelixis

Conditions: Colorectal Cancer

Interventions: XL092, Atezolizumab, Regorafenib

Countries: United States, Australia, Belgium, France, Germany, Hong Kong, Hungary, New Zealand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* 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 Exclusion Criteria:

* Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (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.
* Has uncontrolled, significant intercurrent or recent illness.
* Major surgery (example, gastrointestinal (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 milliseconds (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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (133)

Jonesboro, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Duarte, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Santa Monica, California, United States
Santa Rosa, California, United States
Sylmar, California, United States
Torrance, California, United States
Whittier, California, United States
New Haven, Connecticut, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Marietta, Georgia, United States
Joliet, Illinois, United States
Indianapolis, Indiana, United States
Westwood, Kansas, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
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