Colorectal Cancer Clinical Trial
— STELLAR-303Official title:
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Exelixis |
United States, Australia, Belgium, France, Germany, Hong Kong, Hungary, Korea, Republic of, New Zealand, Poland, Portugal, Singapore, Spain, Taiwan, Thailand, United Kingdom,
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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