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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05425940
Other study ID # XL092-303
Secondary ID 2021-003243-21
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 7, 2022
Est. completion date February 2026

Study information

Verified date March 2024
Source Exelixis
Contact Exelixis Clinical Trials
Phone 1-888-EXELIXIS (888-393-5494)
Email druginfo@exelixis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 874
Est. completion date February 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum. - Documented 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 standard-of-care (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 subject 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 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 (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. - Age 18 years or older on the day of consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Adequate organ and marrow function. - Fertile subjects 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. - Female subjects of childbearing potential must not be pregnant at screening. Exclusion Criteria: - Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or 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. - Subject has uncontrolled, significant intercurrent or recent illness. - Major surgery (e.g., 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
XL092
Supplied as tablets; administered orally daily
Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg 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

Locations

Country Name City State
Australia 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
Belgium Exelixis Clinical Site #43 Antwerp
Belgium Exelixis Clinical Site #51 Brussels
Belgium Exelixis Clinical Site #35 Namur
France 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
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 #127 Hannover Niedersach
Germany Exelixis Clinical Site #91 München
Hong Kong Exelixis Clinical Site #25 Hong Kong
Hong Kong Exelixis Clinical Site #33 Hong Kong
Hungary Exelixis Clinical Site #129 Budapest
Hungary Exelixis Clinical Site #41 Budapest
Hungary Exelixis Clinical Site #48 Debrecen
Hungary Exelixis Clinical Site #122 Gyor
Hungary Exelixis Clinical Site #128 Nyíregyháza Szabolcs-Szatmar-Bereg County
Korea, Republic of Exelixis Clinical Site #36 Goyang-si
Korea, Republic of Exelixis Clinical Site #29 Gyeonggi-do
Korea, Republic of Exelixis Clinical Site #28 Hwasun
Korea, Republic of Exelixis Clinical Site #37 Seongnam-si
Korea, Republic of Exelixis Clinical Site #34 Seoul
Korea, Republic of Exelixis Clinical Site #40 Seoul
Korea, Republic of Exelixis Clinical Site #44 Seoul
Korea, Republic of Exelixis Clinical Site #45 Seoul
Korea, Republic of Exelixis Clinical Site #46 Seoul
Korea, Republic of Exelixis Clinical Site #54 Seoul
Korea, Republic of Exelixis Clinical Site #66 Seoul
New Zealand 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
Poland 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 Warszawa
Portugal Exelixis Clinical Site #108 Almada
Portugal Exelixis Clinical Site #120 Coimbra
Portugal Exelixis Clinical Site #99 Guimarães
Portugal Exelixis Clinical Site #124 Lisboa
Portugal Exelixis Clinical Site #131 Lisboa
Portugal Exelixis Clinical Site #96 Lisboa
Singapore Exelixis Clinical Site #100 Singapore
Singapore Exelixis Clinical Site #132 Singapore
Singapore Exelixis Clinical Site #39 Singapore
Singapore Exelixis Clinical Site #94 Singapore
Singapore Exelixis Clinical Site #98 Singapore
Spain Exelixis Clinical Site #112 Barcelona
Spain Exelixis Clinical Site #21 Barcelona
Spain Exelixis Clinical Site #78 Barcelona
Spain Exelixis Clinical Site #86 Barcelona
Spain Exelixis Clinical Site #95 Lleida
Spain Exelixis Clinical Site #116 Madrid
Spain Exelixis Clinical Site #67 Madrid
Spain Exelixis Clinical Site #72 Madrid
Spain Exelixis Clinical Site #79 Madrid
Spain Exelixis Clinical Site #90 Valencia
Spain Exelixis Clinical Site #121 Zaragoza
Taiwan Exelixis Clinical Site #119 Guishan
Taiwan Exelixis Clinical Site #107 Kaohsiung
Taiwan Exelixis Clinical Site #85 Kaohsiung
Taiwan Exelixis Clinical Site #118 Liuying
Taiwan Exelixis Clinical Site #73 Taichung
Taiwan Exelixis Clinical Site #101 Tainan
Thailand Exelixis Clinical Site #62 Chiang Mai
Thailand Exelixis Clinical Site #92 Hat Yai
United Kingdom Exelixis Clinical Site #110 Birmingham
United Kingdom Exelixis Clinical Site #130 Bristol England
United Kingdom Exelixis Clinical Site #111 Edinburgh
United Kingdom Exelixis Clinical Site #114 London
United Kingdom Exelixis Clinical Site #123 London
United Kingdom Exelixis Clinical Site #115 Romford
United Kingdom Exelixis Clinical Site #126 Sutton
United States Exelixis Clinical Site #15 Albuquerque New Mexico
United States Exelixis Clinical Site #8 Billings Montana
United States Exelixis Clinical Site #17 Bronx New York
United States Exelixis Clinical Site #74 Charlotte North Carolina
United States Exelixis Clinical Site #56 Chattanooga Tennessee
United States Exelixis Clinical Site #6 Cincinnati Ohio
United States Exelixis Clinical Site #9 Duarte California
United States Exelixis Clinical Site #450 Fairfax Virginia
United States Exelixis Clinical Site #24 Greenville South Carolina
United States Exelixis Clinical Site #102 Indianapolis Indiana
United States Exelixis Clinical Site #3 Joliet Illinois
United States Exelixis Clinical Site #65 Jonesboro Alabama
United States Exelixis Clinical Site #55 La Jolla California
United States Exelixis Clinical Site #47 Lexington Kentucky
United States Exelixis Clinical Site #77 Los Angeles California
United States Exelixis Clinical Site #4 Marietta Georgia
United States Exelixis Clinical Site #16 Miami Beach Florida
United States Exelixis Clinical Site #133 Nashville Tennessee
United States Exelixis Clinical Site #76 Nashville Tennessee
United States Exelixis Clinical Site #125 New Haven Connecticut
United States Exelixis Clinical Site #7 New Orleans Louisiana
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 #12 Oklahoma City Oklahoma
United States Exelixis Clinical Site #1 Omaha Nebraska
United States Exelixis Clinical Site #105 Orange California
United States Exelixis Clinical Site #60 Orlando Florida
United States Exelixis Clinical Site #106 Philadelphia Pennsylvania
United States Exelixis Clinical Site #30 Phoenix Arizona
United States Exelixis Clinical Site #103 Pittsburgh Pennsylvania
United States Exelixis Clinical Site #18 Pittsburgh Pennsylvania
United States Exelixis Clinical Site #75 Portland Oregon
United States Exelixis Clinical Site #14 Roanoke Virginia
United States Exelixis Clinical Site #22 Saint Louis Missouri
United States Exelixis Clinical Site #80 Santa Monica California
United States Exelixis Clinical Site #5 Santa Rosa California
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 #82 Sylmar California
United States Exelixis Clinical Site #58 Torrance California
United States Exelixis Clinical Site #70 Tucson Arizona
United States Exelixis Clinical Site #10 Westwood Kansas
United States Exelixis Clinical Site #81 Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Exelixis

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Hong Kong,  Hungary,  Korea, Republic of,  New Zealand,  Poland,  Portugal,  Singapore,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1 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.
Other Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 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.
Other Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1 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.
Primary Overall Survival The primary objective of this study is to evaluate OS of XL092 + atezolizumab versus regorafenib in non-liver metastases (NLM) subjects with MSS/MSI-low mCRC who have progressed during, after, or are intolerant to SOC therapy.
Subjects without liver metastases (NLM) are defined as subjects without active liver metastases at screening as determined on baseline imaging of the liver as performed by CT scan with contrast or MRI.
Definitively treated liver metastases (which includes surgical resection, microwave or radiofrequency ablation, or stereotactic body radiation therapy, but not yttrium-90 or chemoembolization alone) that were treated at least 6 months prior to enrollment with no evidence of radiologic progression on subsequent imaging are considered to be non-active liver metastases.
Approximately 32 months after the first subject is randomized.
Secondary Overall Survival The key secondary objective is to evaluate OS of XL092 + atezolizumab versus regorafenib in all randomized subjects with MSS/MSI-low mCRC who have progressed during, after, or are intolerant to SOC therapy. Approximately 32 months after the first subject is randomized.
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