Study Comparing XL092 and Atezolizumab with Regorafenib for Metastatic Colorectal Cancer
Sponsor: Exelixis
Sponsor score: 40
ClinicalTrials ID:NCT05425940
This clinical trial is testing a new combination of drugs, XL092 and atezolizumab, against regorafenib in patients with metastatic colorectal cancer that has not responded to standard treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to compare the effectiveness of a new drug combination, XL092 and atezolizumab, with an existing drug, regorafenib, in treating patients with metastatic colorectal cancer that is stable or has low instability in its genetic makeup (MSS/MSI-low). These patients have either not responded to, stopped responding to, or cannot tolerate standard cancer treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of colon or rectal cancer.
- Have documented RAS gene status (either mutated or normal).
- Do not have high microsatellite instability or mismatch repair deficiency in the cancer.
- Have received standard cancer treatments for metastatic colorectal cancer but the cancer has progressed or the patient cannot tolerate these treatments.
- Have measurable cancer according to specific medical criteria.
- Can provide a previous or new tumor sample for analysis.
- Have recovered from any side effects of previous treatments to a mild level or better.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ and bone marrow function.
- Agree to use effective contraception during and after the study if fertile.
- Women must not be pregnant at the start of the study.
Exclusion Criteria
- Have previously been treated with XL092, regorafenib, or certain other cancer drugs.
- Have taken a small molecule kinase inhibitor within 2 weeks before starting the study.
- Have received any type of cancer antibody therapy, chemotherapy, or hormonal therapy within 3 weeks (or bevacizumab within 4 weeks) before starting the study.
- Have had radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks before starting the study.
- Have untreated or unstable brain metastases.
- Have uncontrolled or significant recent illness.
- Have had major surgery within 4 weeks before starting the study.
- Are taking corticosteroids or other immunosuppressive medications within 14 days before starting the study.
- Have a heart condition affecting the QT interval on an ECG.
- Have a psychiatric illness that may interfere with the study.
- Are pregnant or breastfeeding.
- Cannot swallow pills or have a condition affecting drug absorption.
- Have allergies to the study drugs.
- Have another active cancer or had another cancer diagnosis within 2 years before starting the study.
- Have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Exelixis Clinical Site #65 | 72401 | Jonesboro | Alabama |
| Exelixis Clinical Site #30 | 85004 | Phoenix | Arizona |
| Exelixis Clinical Site #70 | 85719 | Tucson | Arizona |
| Exelixis Clinical Site #9 | 91010 | Duarte | California |
| Exelixis Clinical Site #55 | 92037 | La Jolla | California |
| Exelixis Clinical Site #77 | 90095 | Los Angeles | California |
| Exelixis Clinical Site #105 | 92868 | Orange | California |
| Exelixis Clinical Site #80 | 90404 | Santa Monica | California |
| Exelixis Clinical Site #5 | 95403 | Santa Rosa | California |
| Exelixis Clinical Site #82 | 91342 | Sylmar | California |
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