XL092: Supplied as tablets; administered orally daily.
Atezolizumab: Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).
Regorafenib: Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants — Up to 32 months
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants — Up to 32 months
Trial sites (133)
Facility
City
Region
Status
Exelixis Clinical Site #65
Jonesboro
Alabama
Exelixis Clinical Site #30
Phoenix
Arizona
Exelixis Clinical Site #70
Tucson
Arizona
Exelixis Clinical Site #9
Duarte
California
Exelixis Clinical Site #55
La Jolla
California
Exelixis Clinical Site #77
Los Angeles
California
Exelixis Clinical Site #105
Orange
California
Exelixis Clinical Site #80
Santa Monica
California
Exelixis Clinical Site #5
Santa Rosa
California
Exelixis Clinical Site #82
Sylmar
California
Exelixis Clinical Site #58
Torrance
California
Exelixis Clinical Site #81
Whittier
California
Exelixis Clinical Site #125
New Haven
Connecticut
Exelixis Clinical Site #16
Miami Beach
Florida
Exelixis Clinical Site #60
Orlando
Florida
Exelixis Clinical Site #4
Marietta
Georgia
Exelixis Clinical Site #3
Joliet
Illinois
Exelixis Clinical Site #102
Indianapolis
Indiana
Exelixis Clinical Site #10
Westwood
Kansas
Exelixis Clinical Site #47
Lexington
Kentucky
Exelixis Clinical Site #7
New Orleans
Louisiana
Exelixis Clinical Site #22
St Louis
Missouri
Exelixis Clinical Site #8
Billings
Montana
Exelixis Clinical Site #1
Omaha
Nebraska
Exelixis Clinical Site #15
Albuquerque
New Mexico
Exelixis Clinical Site #11
New York
New York
Exelixis Clinical Site #59
New York
New York
Exelixis Clinical Site #17
The Bronx
New York
Exelixis Clinical Site #74
Charlotte
North Carolina
Exelixis Clinical Site #6
Cincinnati
Ohio
Exelixis Clinical Site #12
Oklahoma City
Oklahoma
Exelixis Clinical Site #75
Portland
Oregon
Exelixis Clinical Site #106
Philadelphia
Pennsylvania
Exelixis Clinical Site #18
Pittsburgh
Pennsylvania
Exelixis Clinical Site #103
Pittsburgh
Pennsylvania
Exelixis Clinical Site #24
Greenville
South Carolina
Exelixis Clinical Site #56
Chattanooga
Tennessee
Exelixis Clinical Site #76
Nashville
Tennessee
Exelixis Clinical Site #133
Nashville
Tennessee
Exelixis Clinical Site #450
Fairfax
Virginia
+ 93 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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