Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
NCT ID: NCT05425940
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
901 participants
INTERVENTIONAL
2022-09-07
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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XL092 + Atezolizumab
Participants with mCRC will receive XL092 + atezolizumab.
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
Participants with mCRC will receive active comparator of regorafenib.
Regorafenib
Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Exelixis
Locations
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Exelixis Clinical Site #65
Jonesboro, Alabama, United States
Exelixis Clinical Site #30
Phoenix, Arizona, United States
Exelixis Clinical Site #70
Tucson, Arizona, United States
Exelixis Clinical Site #9
Duarte, California, United States
Exelixis Clinical Site #55
La Jolla, California, United States
Exelixis Clinical Site #77
Los Angeles, California, United States
Exelixis Clinical Site #105
Orange, California, United States
Exelixis Clinical Site #80
Santa Monica, California, United States
Exelixis Clinical Site #5
Santa Rosa, California, United States
Exelixis Clinical Site #82
Sylmar, California, United States
Exelixis Clinical Site #58
Torrance, California, United States
Exelixis Clinical Site #81
Whittier, California, United States
Exelixis Clinical Site #125
New Haven, Connecticut, United States
Exelixis Clinical Site #16
Miami Beach, Florida, United States
Exelixis Clinical Site #60
Orlando, Florida, United States
Exelixis Clinical Site #4
Marietta, Georgia, United States
Exelixis Clinical Site #3
Joliet, Illinois, United States
Exelixis Clinical Site #102
Indianapolis, Indiana, United States
Exelixis Clinical Site #10
Westwood, Kansas, United States
Exelixis Clinical Site #47
Lexington, Kentucky, United States
Exelixis Clinical Site #7
New Orleans, Louisiana, United States
Exelixis Clinical Site #22
St Louis, Missouri, United States
Exelixis Clinical Site #8
Billings, Montana, United States
Exelixis Clinical Site #1
Omaha, Nebraska, United States
Exelixis Clinical Site #15
Albuquerque, New Mexico, United States
Exelixis Clinical Site #11
New York, New York, United States
Exelixis Clinical Site #59
New York, New York, United States
Exelixis Clinical Site #17
The Bronx, New York, United States
Exelixis Clinical Site #74
Charlotte, North Carolina, United States
Exelixis Clinical Site #6
Cincinnati, Ohio, United States
Exelixis Clinical Site #12
Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #75
Portland, Oregon, United States
Exelixis Clinical Site #106
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #18
Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #103
Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #24
Greenville, South Carolina, United States
Exelixis Clinical Site #56
Chattanooga, Tennessee, United States
Exelixis Clinical Site #76
Nashville, Tennessee, United States
Exelixis Clinical Site #133
Nashville, Tennessee, United States
Exelixis Clinical Site #450
Fairfax, Virginia, United States
Exelixis Clinical Site #14
Roanoke, Virginia, United States
Exelixis Clinical Site #13
Seattle, Washington, United States
Exelixis Clinical Site #32
Seattle, Washington, United States
Exelixis Clinical Site #89
Seattle, Washington, United States
Exelixis Clinical Site #2
Spokane, Washington, United States
Exelixis Clinical Site #83
Albury, , Australia
Exelixis Clinical Site #53
Bankstown, , Australia
Exelixis Clinical Site #117
Bedford Park, , Australia
Exelixis Clinical Site #97
Heidelberg, , Australia
Exelixis Clinical Site #19
Melbourne, , Australia
Exelixis Clinical Site #23
Melbourne, , Australia
Exelixis Clinical Site #27
Port Macquarie, , Australia
Exelixis Clinical Site #64
Woodville South, , Australia
Exelixis Clinical Site #43
Antwerp, , Belgium
Exelixis Clinical Site #51
Brussels, , Belgium
Exelixis Clinical Site #35
Namur, , Belgium
Exelixis Clinical Site #52
Besançon, , France
Exelixis Clinical Site #84
Dijon, , France
Exelixis Clinical Site #88
Herbault, , France
Exelixis Clinical Site #71
Lyon, , France
Exelixis Clinical Site #87
Marseille, , France
Exelixis Clinical Site #38
Paris, , France
Exelixis Clinical Site #93
Suresnes, , France
Exelixis Clinical Site #127
Hanover, Niedersach, Germany
Exelixis Clinical Site #109
Dresden, , Germany
Exelixis Clinical Site #113
Frankfurt am Main, , Germany
Exelixis Clinical Site #61
Hamburg, , Germany
Exelixis Clinical Site #63
Hamburg, , Germany
Exelixis Clinical Site #91
München, , Germany
Exelixis Clinical Site #25
Hong Kong, , Hong Kong
Exelixis Clinical Site #33
Hong Kong, , Hong Kong
Exelixis Clinical Site #128
Nyíregyháza, Szabolcs-Szatmar-Bereg County, Hungary
Exelixis Clinical Site #41
Budapest, , Hungary
Exelixis Clinical Site #129
Budapest, , Hungary
Exelixis Clinical Site #48
Debrecen, , Hungary
Exelixis Clinical Site #122
Győr, , Hungary
Exelixis Clinical Site #57
Auckland, , New Zealand
Exelixis Clinical Site #49
Dunedin, , New Zealand
Exelixis Clinical Site #69
Hamilton, , New Zealand
Exelixis Clinical Site #104
Wellington, , New Zealand
Exelixis Clinical Site #20
Bydgoszcz, , Poland
Exelixis Clinical Site #68
Opole, , Poland
Exelixis Clinical Site #26
Siedlce, , Poland
Exelixis Clinical Site #42
Tomaszów Mazowiecki, , Poland
Exelixis Clinical Site #31
Warsaw, , Poland
Exelixis Clinical Site #108
Almada, , Portugal
Exelixis Clinical Site #120
Coimbra, , Portugal
Exelixis Clinical Site #99
Guimarães, , Portugal
Exelixis Clinical Site #131
Lisbon, , Portugal
Exelixis Clinical Site #124
Lisbon, , Portugal
Exelixis Clinical Site #96
Lisbon, , Portugal
Exelixis Clinical Site #132
Singapore, , Singapore
Exelixis Clinical Site #100
Singapore, , Singapore
Exelixis Clinical Site #39
Singapore, , Singapore
Exelixis Clinical Site #98
Singapore, , Singapore
Exelixis Clinical Site #94
Singapore, , Singapore
Exelixis Clinical Site #36
Goyang-si, , South Korea
Exelixis Clinical Site #29
Gyeonggi-do, , South Korea
Exelixis Clinical Site #28
Hwasun, , South Korea
Exelixis Clinical Site #37
Seongnam-si, , South Korea
Exelixis Clinical Site #34
Seoul, , South Korea
Exelixis Clinical Site #45
Seoul, , South Korea
Exelixis Clinical Site #66
Seoul, , South Korea
Exelixis Clinical Site #46
Seoul, , South Korea
Exelixis Clinical Site #54
Seoul, , South Korea
Exelixis Clinical Site #44
Seoul, , South Korea
Exelixis Clinical Site #40
Seoul, , South Korea
Exelixis Clinical Site #78
Barcelona, , Spain
Exelixis Clinical Site #21
Barcelona, , Spain
Exelixis Clinical Site #86
Barcelona, , Spain
Exelixis Clinical Site #112
Barcelona, , Spain
Exelixis Clinical Site #95
Lleida, , Spain
Exelixis Clinical Site #116
Madrid, , Spain
Exelixis Clinical Site #72
Madrid, , Spain
Exelixis Clinical Site #67
Madrid, , Spain
Exelixis Clinical Site #79
Madrid, , Spain
Exelixis Clinical Site #90
Valencia, , Spain
Exelixis Clinical Site #121
Zaragoza, , Spain
Exelixis Clinical Site #119
Guishan, , Taiwan
Exelixis Clinical Site #85
Kaohsiung City, , Taiwan
Exelixis Clinical Site #107
Kaohsiung City, , Taiwan
Exelixis Clinical Site #118
Liuying, , Taiwan
Exelixis Clinical Site #73
Taichung, , Taiwan
Exelixis Clinical Site #101
Tainan City, , Taiwan
Exelixis Clinical Site #62
Chiang Mai, , Thailand
Exelixis Clinical Site #92
Hat Yai, , Thailand
Exelixis Clinical Site #130
Bristol, England, United Kingdom
Exelixis Clinical Site #110
Birmingham, , United Kingdom
Exelixis Clinical Site #111
Edinburgh, , United Kingdom
Exelixis Clinical Site #123
London, , United Kingdom
Exelixis Clinical Site #114
London, , United Kingdom
Exelixis Clinical Site #115
Romford, , United Kingdom
Exelixis Clinical Site #126
Sutton, , United Kingdom
Countries
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References
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Hecht JR, Park YS, Tabernero J, Lee MA, Lee S, Virgili AC, Van den Eynde M, Fontana E, Fakih M, Asghari G, So J, Stein A, Dubreuil O, Bodnar L, He CS, Wang G, Smith R, Eng C, Saeed A; STELLAR-303 study investigators. Zanzalintinib plus atezolizumab versus regorafenib in refractory colorectal cancer (STELLAR-303): a randomised, open-label, phase 3 trial. Lancet. 2025 Oct 20:S0140-6736(25)02025-2. doi: 10.1016/S0140-6736(25)02025-2. Online ahead of print.
Saeed A, Tabernero J, Parikh A, Van den Eynde M, Karthaus M, Gerlinger M, Wang Z, Wang G, Smith R, Hecht JR. STELLAR-303: randomized phase III study of zanzalintinib + atezolizumab in previously treated metastatic colorectal cancer. Future Oncol. 2024;20(24):1733-1743. doi: 10.1080/14796694.2024.2352276. Epub 2024 Jul 23.
Other Identifiers
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2021-003243-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
XL092-303
Identifier Type: -
Identifier Source: org_study_id
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