Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer (STELLAR-303)

October 22, 2025 updated by: Exelixis

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

901

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Albury, Australia, 2640
        • Exelixis Clinical Site #83
      • Bankstown, Australia, 2200
        • Exelixis Clinical Site #53
      • Bedford Park, Australia, 5042
        • Exelixis Clinical Site #117
      • Heidelberg, Australia, 3084
        • Exelixis Clinical Site #97
      • Melbourne, Australia, 3002
        • Exelixis Clinical Site #19
      • Melbourne, Australia, 3021
        • Exelixis Clinical Site #23
      • Port Macquarie, Australia, 2444
        • Exelixis Clinical Site #27
      • Woodville South, Australia, 5011
        • Exelixis Clinical Site #64
  • Belgium
      • Antwerp, Belgium, 2300
        • Exelixis Clinical Site #43
      • Brussels, Belgium, 1200
        • Exelixis Clinical Site #51
      • Namur, Belgium, 5000
        • Exelixis Clinical Site #35
  • France
      • Besançon, France, 25030
        • Exelixis Clinical Site #52
      • Dijon, France, 21079
        • Exelixis Clinical Site #84
      • Herbault, France, 34298
        • Exelixis Clinical Site #88
      • Lyon, France, 69008
        • Exelixis Clinical Site #71
      • Marseille, France, 13385
        • Exelixis Clinical Site #87
      • Paris, France, 75020
        • Exelixis Clinical Site #38
      • Suresnes, France, 92150
        • Exelixis Clinical Site #93
  • Germany
      • Dresden, Germany, 01307
        • Exelixis Clinical Site #109
      • Frankfurt am Main, Germany, 60488
        • Exelixis Clinical Site #113
      • Hamburg, Germany, 20249
        • Exelixis Clinical Site #61
      • Hamburg, Germany, 22763
        • Exelixis Clinical Site #63
      • München, Germany, 81737
        • Exelixis Clinical Site #91
    • Niedersach
      • Hanover, Niedersach, Germany, 30625
        • Exelixis Clinical Site #127
  • Hong Kong
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #25
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #33
  • Hungary
      • Budapest, Hungary, 1097
        • Exelixis Clinical Site #41
      • Budapest, Hungary, 1122
        • Exelixis Clinical Site #129
      • Debrecen, Hungary, 4302
        • Exelixis Clinical Site #48
      • Győr, Hungary, 9024
        • Exelixis Clinical Site #122
    • Szabolcs-Szatmar-Bereg County
      • Nyíregyháza, Szabolcs-Szatmar-Bereg County, Hungary, 4400
        • Exelixis Clinical Site #128
  • New Zealand
      • Auckland, New Zealand, 1023
        • Exelixis Clinical Site #57
      • Dunedin, New Zealand, 9016
        • Exelixis Clinical Site #49
      • Hamilton, New Zealand, 3204
        • Exelixis Clinical Site #69
      • Wellington, New Zealand, 6021
        • Exelixis Clinical Site #104
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Exelixis Clinical Site #20
      • Opole, Poland, 45-061
        • Exelixis Clinical Site #68
      • Siedlce, Poland, 08-110
        • Exelixis Clinical Site #26
      • Tomaszów Mazowiecki, Poland, 97-200
        • Exelixis Clinical Site #42
      • Warsaw, Poland, 02-507
        • Exelixis Clinical Site #31
  • Portugal
      • Almada, Portugal, 2805-267
        • Exelixis Clinical Site #108
      • Coimbra, Portugal, 3000-075
        • Exelixis Clinical Site #120
      • Guimarães, Portugal, 4835-044
        • Exelixis Clinical Site #99
      • Lisbon, Portugal, 1500-650
        • Exelixis Clinical Site #131
      • Lisbon, Portugal, 1649-035
        • Exelixis Clinical Site #124
      • Lisbon, Portugal, 400-038
        • Exelixis Clinical Site #96
  • Singapore
      • Singapore, Singapore, 119228
        • Exelixis Clinical Site #132
      • Singapore, Singapore, 168583
        • Exelixis Clinical Site #100
      • Singapore, Singapore, 217562
        • Exelixis Clinical Site #39
      • Singapore, Singapore, 258499
        • Exelixis Clinical Site #98
      • Singapore, Singapore, 329563
        • Exelixis Clinical Site #94
  • South Korea
      • Goyang-si, South Korea, 10408
        • Exelixis Clinical Site #36
      • Gyeonggi-do, South Korea, 14068
        • Exelixis Clinical Site #29
      • Hwasun, South Korea, 58128
        • Exelixis Clinical Site #28
      • Seongnam-si, South Korea, 13620
        • Exelixis Clinical Site #37
      • Seoul, South Korea, 03080
        • Exelixis Clinical Site #34
      • Seoul, South Korea, 03722
        • Exelixis Clinical Site #45
      • Seoul, South Korea, 05505
        • Exelixis Clinical Site #66
      • Seoul, South Korea, 06351
        • Exelixis Clinical Site #46
      • Seoul, South Korea, 06591
        • Exelixis Clinical Site #54
      • Seoul, South Korea, 08308
        • Exelixis Clinical Site #44
      • Seoul, South Korea
        • Exelixis Clinical Site #40
  • Spain
      • Barcelona, Spain, 08023
        • Exelixis Clinical Site #78
      • Barcelona, Spain, 08025
        • Exelixis Clinical Site #21
      • Barcelona, Spain, 08035
        • Exelixis Clinical Site #86
      • Barcelona, Spain, 08908
        • Exelixis Clinical Site #112
      • Lleida, Spain, 25198
        • Exelixis Clinical Site #95
      • Madrid, Spain, 28007
        • Exelixis Clinical Site #116
      • Madrid, Spain, 28034
        • Exelixis Clinical Site #72
      • Madrid, Spain, 28041
        • Exelixis Clinical Site #67
      • Madrid, Spain, 28050
        • Exelixis Clinical Site #79
      • Valencia, Spain, 46014
        • Exelixis Clinical Site #90
      • Zaragoza, Spain, 50009
        • Exelixis Clinical Site #121
  • Taiwan
      • Guishan, Taiwan, 333
        • Exelixis Clinical Site #119
      • Kaohsiung City, Taiwan, 807
        • Exelixis Clinical Site #85
      • Kaohsiung City, Taiwan, 833
        • Exelixis Clinical Site #107
      • Liuying, Taiwan, 73657
        • Exelixis Clinical Site #118
      • Taichung, Taiwan, 40447
        • Exelixis Clinical Site #73
      • Tainan City, Taiwan, 704
        • Exelixis Clinical Site #101
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Exelixis Clinical Site #62
      • Hat Yai, Thailand, 90110
        • Exelixis Clinical Site #92
  • United Kingdom
      • Birmingham, United Kingdom, B95SS
        • Exelixis Clinical Site #110
      • Edinburgh, United Kingdom, EH42XU
        • Exelixis Clinical Site #111
      • London, United Kingdom, EC1A 7BE
        • Exelixis Clinical Site #123
      • London, United Kingdom, W1G 6AD
        • Exelixis Clinical Site #114
      • Romford, United Kingdom, RM70AG
        • Exelixis Clinical Site #115
      • Sutton, United Kingdom, SM2 5PT
        • Exelixis Clinical Site #126
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Exelixis Clinical Site #130
  • United States
    • Alabama
      • Jonesboro, Alabama, United States, 72401
        • Exelixis Clinical Site #65
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Exelixis Clinical Site #30
      • Tucson, Arizona, United States, 85719
        • Exelixis Clinical Site #70
    • California
      • Duarte, California, United States, 91010
        • Exelixis Clinical Site #9
      • La Jolla, California, United States, 92037
        • Exelixis Clinical Site #55
      • Los Angeles, California, United States, 90095
        • Exelixis Clinical Site #77
      • Orange, California, United States, 92868
        • Exelixis Clinical Site #105
      • Santa Monica, California, United States, 90404
        • Exelixis Clinical Site #80
      • Santa Rosa, California, United States, 95403
        • Exelixis Clinical Site #5
      • Sylmar, California, United States, 91342
        • Exelixis Clinical Site #82
      • Torrance, California, United States, 90505
        • Exelixis Clinical Site #58
      • Whittier, California, United States, 90602
        • Exelixis Clinical Site #81
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Exelixis Clinical Site #125
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Exelixis Clinical Site #16
      • Orlando, Florida, United States, 32804
        • Exelixis Clinical Site #60
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Exelixis Clinical Site #4
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Exelixis Clinical Site #3
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Exelixis Clinical Site #102
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Exelixis Clinical Site #10
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Exelixis Clinical Site #47
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Exelixis Clinical Site #7
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Exelixis Clinical Site #22
    • Montana
      • Billings, Montana, United States, 59102
        • Exelixis Clinical Site #8
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Exelixis Clinical Site #1
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Exelixis Clinical Site #15
    • New York
      • New York, New York, United States, 10016
        • Exelixis Clinical Site #11
      • New York, New York, United States, 10029
        • Exelixis Clinical Site #59
      • The Bronx, New York, United States, 10461
        • Exelixis Clinical Site #17
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Exelixis Clinical Site #74
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Exelixis Clinical Site #6
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73142
        • Exelixis Clinical Site #12
    • Oregon
      • Portland, Oregon, United States, 97210
        • Exelixis Clinical Site #75
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Exelixis Clinical Site #106
      • Pittsburgh, Pennsylvania, United States, 15212
        • Exelixis Clinical Site #18
      • Pittsburgh, Pennsylvania, United States, 15232
        • Exelixis Clinical Site #103
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Exelixis Clinical Site #24
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Exelixis Clinical Site #56
      • Nashville, Tennessee, United States, 37203
        • Exelixis Clinical Site #76
      • Nashville, Tennessee, United States, 37232
        • Exelixis Clinical Site #133
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Exelixis Clinical Site #450
      • Roanoke, Virginia, United States, 24014
        • Exelixis Clinical Site #14
    • Washington
      • Seattle, Washington, United States, 98101
        • Exelixis Clinical Site #13
      • Seattle, Washington, United States, 98104
        • Exelixis Clinical Site #32
      • Seattle, Washington, United States, 98109
        • Exelixis Clinical Site #89
      • Spokane, Washington, United States, 99208
        • Exelixis Clinical Site #2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XL092 + Atezolizumab
Participants with mCRC will receive XL092 + atezolizumab.
Drug: XL092
Supplied as tablets; administered orally daily.
Drug: 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).
Other Names:
  • Tecentriq®
Active Comparator: Regorafenib
Participants with mCRC will receive active comparator of regorafenib.
Drug: Regorafenib
Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.
Other Names:
  • Stivarga®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants
Time Frame: Up to 32 months
Up to 32 months
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants
Time Frame: Up to 32 months
Up to 32 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS) as Assessed by the Investigator
Time Frame: Up to 26 months
Up to 26 months
Duration of Response (DOR) as Assessed by the Investigator
Time Frame: Up to 36 months
Up to 36 months
Objective Response Rate (ORR) as Assessed by the Investigator
Time Frame: Up to 36 months
Up to 36 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 36 months
Up to 36 months
Maximum Observed Plasma Drug Concentration (Cmax) of XL092
Time Frame: Predose up to 72 hours postdose
Predose up to 72 hours postdose
Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092
Time Frame: Predose up to 72 hours postdose
Predose up to 72 hours postdose
Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab
Time Frame: Up to 36 months
Up to 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1
Time Frame: Approximately 26 months after the first subject is randomized.
Defined as the time randomization to the earlier of either radiographic progressive disease (PD) as assessed by the Investigator per RECIST 1.1 or death from any cause.
Approximately 26 months after the first subject is randomized.
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
Time Frame: Up to 36 months after the first subject is randomized.
Defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) as assessed by the Investigator per RECIST 1.1 criteria.
Up to 36 months after the first subject is randomized.
Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1
Time Frame: Up to 36 months after the first subject is randomized.
Defined as the time from the first documentation of objective response (subsequently confirmed at a visit ≥ 28 days later) to either radiographic disease progression or death due to any cause.
Up to 36 months after the first subject is randomized.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Investigators

  • Study Director: Medical Director, Exelixis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL092-303
  • 2021-003243-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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