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Clinical Trials in Australia / NCT05425940
Active, not recruiting Phase 3

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

NCT05425940 · tracked via the Priya Life Science Australia tracker
Sponsor
Phase
Phase 3
Started
2022-09-07
Last updated
2026-07-17

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

XL092 →Atezolizumab →Regorafenib →

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)

Trial sites (133)

FacilityCityRegionStatus
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.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Stivarga (regorafenib) drug profile →

More Exelixis trials in Australia

Other trials for the same condition

Official registry record

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.

View NCT05425940 on ClinicalTrials.gov ↗ ← All trials in Australia