A Phase 3 interventional study of XL092 and Atezolizumab in Colorectal Cancer, sponsored by Exelixis. Active, not recruiting at 133 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Exelixis · Phase 3, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 901 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Exelixis is the lead sponsor of 57 studies on the registry; 12 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
Has received SOC anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants with mCRC will receive XL092 + atezolizumab.
Drug: XL092 · Drug: Atezolizumab
Participants with mCRC will receive active comparator of regorafenib.
Drug: Regorafenib
Supplied as tablets; administered orally daily.
Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).
Also known as: Tecentriq®
Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.
Also known as: Stivarga®
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants
Time frame: 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
Progression-Free Survival (PFS) as Assessed by the Investigator
Time frame: Up to 26 months
Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to 36 months
Objective Response Rate (ORR) as Assessed by the Investigator
Time frame: Up to 36 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 36 months
Maximum Observed Plasma Drug Concentration (Cmax) of XL092
Time frame: Predose up to 72 hours postdose
Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092
Time frame: Predose up to 72 hours postdose
Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab
Time frame: Up to 36 months
Showing the first 100 of 133 sites across 16 countries.
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Exelixis