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New hope for Tough-to-Treat colorectal cancer?

NCT ID NCT05425940

Disease control Sponsor: Exelixis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a new drug combination (XL092 plus atezolizumab) works better than the current standard drug regorafenib for people with advanced colorectal cancer that has not responded to other treatments. About 900 participants will receive either the new combo or regorafenib. The main goal is to see if the new combo helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XL092 and atezolizumab (Tecentriq)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced colorectal cancer who have run out of standard therapies, potentially extending survival.
What could go wrong
This is a large phase 3 trial, but the experimental drug combination may not prove better than the existing drug regorafenib. Side effects from the combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

901 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Exelixis Clinical Site #1

    Omaha, Nebraska, 68130, United States

  • Exelixis Clinical Site #10

    Westwood, Kansas, 66205, United States

  • Exelixis Clinical Site #100

    Singapore, 168583, Singapore

  • Exelixis Clinical Site #101

    Tainan, 704, Taiwan

  • Exelixis Clinical Site #102

    Indianapolis, Indiana, 46250, United States

  • Exelixis Clinical Site #103

    Pittsburgh, Pennsylvania, 15232, United States

  • Exelixis Clinical Site #104

    Wellington, 6021, New Zealand

  • Exelixis Clinical Site #105

    Orange, California, 92868, United States

  • Exelixis Clinical Site #106

    Philadelphia, Pennsylvania, 19107, United States

  • Exelixis Clinical Site #107

    Kaohsiung City, 833, Taiwan

  • Exelixis Clinical Site #108

    Almada, 2805-267, Portugal

  • Exelixis Clinical Site #109

    Dresden, 01307, Germany

  • Exelixis Clinical Site #11

    New York, New York, 10016, United States

  • Exelixis Clinical Site #110

    Birmingham, B95SS, United Kingdom

  • Exelixis Clinical Site #111

    Edinburgh, EH42XU, United Kingdom

  • Exelixis Clinical Site #112

    Barcelona, 08908, Spain

  • Exelixis Clinical Site #113

    Frankfurt am Main, 60488, Germany

  • Exelixis Clinical Site #114

    London, W1G 6AD, United Kingdom

  • Exelixis Clinical Site #115

    Romford, RM70AG, United Kingdom

  • Exelixis Clinical Site #116

    Madrid, 28007, Spain

  • Exelixis Clinical Site #117

    Bedford Park, 5042, Australia

  • Exelixis Clinical Site #118

    Liuying, 73657, Taiwan

  • Exelixis Clinical Site #119

    Guishan, 333, Taiwan

  • Exelixis Clinical Site #12

    Oklahoma City, Oklahoma, 73142, United States

  • Exelixis Clinical Site #120

    Coimbra, 3000-075, Portugal

  • Exelixis Clinical Site #121

    Zaragoza, 50009, Spain

  • Exelixis Clinical Site #122

    Győr, 9024, Hungary

  • Exelixis Clinical Site #123

    London, EC1A 7BE, United Kingdom

  • Exelixis Clinical Site #124

    Lisbon, 1649-035, Portugal

  • Exelixis Clinical Site #125

    New Haven, Connecticut, 06510, United States

  • Exelixis Clinical Site #126

    Sutton, SM2 5PT, United Kingdom

  • Exelixis Clinical Site #127

    Hanover, Niedersach, 30625, Germany

  • Exelixis Clinical Site #128

    Nyíregyháza, Szabolcs-Szatmar-Bereg County, 4400, Hungary

  • Exelixis Clinical Site #129

    Budapest, 1122, Hungary

  • Exelixis Clinical Site #13

    Seattle, Washington, 98101, United States

  • Exelixis Clinical Site #130

    Bristol, England, BS2 8ED, United Kingdom

  • Exelixis Clinical Site #131

    Lisbon, 1500-650, Portugal

  • Exelixis Clinical Site #132

    Singapore, 119228, Singapore

  • Exelixis Clinical Site #133

    Nashville, Tennessee, 37232, United States

  • Exelixis Clinical Site #14

    Roanoke, Virginia, 24014, United States

  • Exelixis Clinical Site #15

    Albuquerque, New Mexico, 87131, United States

  • Exelixis Clinical Site #16

    Miami Beach, Florida, 33140, United States

  • Exelixis Clinical Site #17

    The Bronx, New York, 10461, United States

  • Exelixis Clinical Site #18

    Pittsburgh, Pennsylvania, 15212, United States

  • Exelixis Clinical Site #19

    Melbourne, 3002, Australia

  • Exelixis Clinical Site #2

    Spokane, Washington, 99208, United States

  • Exelixis Clinical Site #20

    Bydgoszcz, 85-796, Poland

  • Exelixis Clinical Site #21

    Barcelona, 08025, Spain

  • Exelixis Clinical Site #22

    St Louis, Missouri, 63141, United States

  • Exelixis Clinical Site #23

    Melbourne, 3021, Australia

  • Exelixis Clinical Site #24

    Greenville, South Carolina, 29607, United States

  • Exelixis Clinical Site #25

    Hong Kong, Hong Kong

  • Exelixis Clinical Site #26

    Siedlce, 08-110, Poland

  • Exelixis Clinical Site #27

    Port Macquarie, 2444, Australia

  • Exelixis Clinical Site #28

    Hwasun, 58128, South Korea

  • Exelixis Clinical Site #29

    Gyeonggi-do, 14068, South Korea

  • Exelixis Clinical Site #3

    Joliet, Illinois, 60435, United States

  • Exelixis Clinical Site #30

    Phoenix, Arizona, 85004, United States

  • Exelixis Clinical Site #31

    Warsaw, 02-507, Poland

  • Exelixis Clinical Site #32

    Seattle, Washington, 98104, United States

  • Exelixis Clinical Site #33

    Hong Kong, Hong Kong

  • Exelixis Clinical Site #34

    Seoul, 03080, South Korea

  • Exelixis Clinical Site #35

    Namur, 5000, Belgium

  • Exelixis Clinical Site #36

    Goyang-si, 10408, South Korea

  • Exelixis Clinical Site #37

    Seongnam-si, 13620, South Korea

  • Exelixis Clinical Site #38

    Paris, 75020, France

  • Exelixis Clinical Site #39

    Singapore, 217562, Singapore

  • Exelixis Clinical Site #4

    Marietta, Georgia, 30060, United States

  • Exelixis Clinical Site #40

    Seoul, South Korea

  • Exelixis Clinical Site #41

    Budapest, 1097, Hungary

  • Exelixis Clinical Site #42

    Tomaszów Mazowiecki, 97-200, Poland

  • Exelixis Clinical Site #43

    Antwerp, 2300, Belgium

  • Exelixis Clinical Site #44

    Seoul, 08308, South Korea

  • Exelixis Clinical Site #45

    Seoul, 03722, South Korea

  • Exelixis Clinical Site #450

    Fairfax, Virginia, 22031, United States

  • Exelixis Clinical Site #46

    Seoul, 06351, South Korea

  • Exelixis Clinical Site #47

    Lexington, Kentucky, 40536, United States

  • Exelixis Clinical Site #48

    Debrecen, 4302, Hungary

  • Exelixis Clinical Site #49

    Dunedin, 9016, New Zealand

  • Exelixis Clinical Site #5

    Santa Rosa, California, 95403, United States

  • Exelixis Clinical Site #51

    Brussels, 1200, Belgium

  • Exelixis Clinical Site #52

    Besançon, 25030, France

  • Exelixis Clinical Site #53

    Bankstown, 2200, Australia

  • Exelixis Clinical Site #54

    Seoul, 06591, South Korea

  • Exelixis Clinical Site #55

    La Jolla, California, 92037, United States

  • Exelixis Clinical Site #56

    Chattanooga, Tennessee, 37404, United States

  • Exelixis Clinical Site #57

    Auckland, 1023, New Zealand

  • Exelixis Clinical Site #58

    Torrance, California, 90505, United States

  • Exelixis Clinical Site #59

    New York, New York, 10029, United States

  • Exelixis Clinical Site #6

    Cincinnati, Ohio, 45219, United States

  • Exelixis Clinical Site #60

    Orlando, Florida, 32804, United States

  • Exelixis Clinical Site #61

    Hamburg, 20249, Germany

  • Exelixis Clinical Site #62

    Chiang Mai, 50200, Thailand

  • Exelixis Clinical Site #63

    Hamburg, 22763, Germany

  • Exelixis Clinical Site #64

    Woodville South, 5011, Australia

  • Exelixis Clinical Site #65

    Jonesboro, Alabama, 72401, United States

  • Exelixis Clinical Site #66

    Seoul, 05505, South Korea

  • Exelixis Clinical Site #67

    Madrid, 28041, Spain

  • Exelixis Clinical Site #68

    Opole, 45-061, Poland

  • Exelixis Clinical Site #69

    Hamilton, 3204, New Zealand

  • Exelixis Clinical Site #7

    New Orleans, Louisiana, 70112, United States

  • Exelixis Clinical Site #70

    Tucson, Arizona, 85719, United States

  • Exelixis Clinical Site #71

    Lyon, 69008, France

  • Exelixis Clinical Site #72

    Madrid, 28034, Spain

  • Exelixis Clinical Site #73

    Taichung, 40447, Taiwan

  • Exelixis Clinical Site #74

    Charlotte, North Carolina, 28204, United States

  • Exelixis Clinical Site #75

    Portland, Oregon, 97210, United States

  • Exelixis Clinical Site #76

    Nashville, Tennessee, 37203, United States

  • Exelixis Clinical Site #77

    Los Angeles, California, 90095, United States

  • Exelixis Clinical Site #78

    Barcelona, 08023, Spain

  • Exelixis Clinical Site #79

    Madrid, 28050, Spain

  • Exelixis Clinical Site #8

    Billings, Montana, 59102, United States

  • Exelixis Clinical Site #80

    Santa Monica, California, 90404, United States

  • Exelixis Clinical Site #81

    Whittier, California, 90602, United States

  • Exelixis Clinical Site #82

    Sylmar, California, 91342, United States

  • Exelixis Clinical Site #83

    Albury, 2640, Australia

  • Exelixis Clinical Site #84

    Dijon, 21079, France

  • Exelixis Clinical Site #85

    Kaohsiung City, 807, Taiwan

  • Exelixis Clinical Site #86

    Barcelona, 08035, Spain

  • Exelixis Clinical Site #87

    Marseille, 13385, France

  • Exelixis Clinical Site #88

    Herbault, 34298, France

  • Exelixis Clinical Site #89

    Seattle, Washington, 98109, United States

  • Exelixis Clinical Site #9

    Duarte, California, 91010, United States

  • Exelixis Clinical Site #90

    Valencia, 46014, Spain

  • Exelixis Clinical Site #91

    München, 81737, Germany

  • Exelixis Clinical Site #92

    Hat Yai, 90110, Thailand

  • Exelixis Clinical Site #93

    Suresnes, 92150, France

  • Exelixis Clinical Site #94

    Singapore, 329563, Singapore

  • Exelixis Clinical Site #95

    Lleida, 25198, Spain

  • Exelixis Clinical Site #96

    Lisbon, 400-038, Portugal

  • Exelixis Clinical Site #97

    Heidelberg, 3084, Australia

  • Exelixis Clinical Site #98

    Singapore, 258499, Singapore

  • Exelixis Clinical Site #99

    Guimarães, 4835-044, Portugal

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