Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
- Summary
- 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.
- Acronym
- STELLAR-303
- Short title
- Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
- Official title
- A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-01-31
- First posted
- 2022-06-21
- Registry last updated
- 2026-07-17
- Primary completion date
- 2026-06-16
- Start date
- 2022-09-07
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Exelixis
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05425940
- ClinicalTrials.gov ID
- NCT05425940
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants
Timeframe: Up to 32 months
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants
Timeframe: Up to 32 months
Progression-Free Survival (PFS) as Assessed by the Investigator
Timeframe: Up to 26 months
Duration of Response (DOR) as Assessed by the Investigator
Timeframe: Up to 36 months
Objective Response Rate (ORR) as Assessed by the Investigator
Timeframe: Up to 36 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 36 months
Maximum Observed Plasma Drug Concentration (Cmax) of XL092
Timeframe: Predose up to 72 hours postdose
Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092
Timeframe: Predose up to 72 hours postdose
Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab
Timeframe: Up to 36 months
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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.
- Exelixis Clinical Site #65Jonesboro, United States
- Exelixis Clinical Site #30Phoenix, United States
- Exelixis Clinical Site #70Tucson, United States
- Exelixis Clinical Site #9Duarte, United States
- Exelixis Clinical Site #55La Jolla, United States
- Exelixis Clinical Site #77Los Angeles, United States
- Exelixis Clinical Site #105Orange, United States
- Exelixis Clinical Site #80Santa Monica, United States
- Exelixis Clinical Site #5Santa Rosa, United States
- Exelixis Clinical Site #82Sylmar, United States
- Exelixis Clinical Site #58Torrance, United States
- Exelixis Clinical Site #81Whittier, United States
- Exelixis Clinical Site #125New Haven, United States
- Exelixis Clinical Site #16Miami Beach, United States
- Exelixis Clinical Site #60Orlando, United States
- Exelixis Clinical Site #4Marietta, United States
- Exelixis Clinical Site #3Joliet, United States
- Exelixis Clinical Site #102Indianapolis, United States
- Exelixis Clinical Site #10Westwood, United States
- Exelixis Clinical Site #47Lexington, United States
- Exelixis Clinical Site #7New Orleans, United States
- Exelixis Clinical Site #22St Louis, United States
- Exelixis Clinical Site #8Billings, United States
- Exelixis Clinical Site #1Omaha, United States
- Exelixis Clinical Site #15Albuquerque, United States
And 108 more, listed on the interactive page.
- PubMed 41130252Related publication
- PubMed 39041200Related publication
Other registry identifiers
- 2021-003243-21
Related records
Drugs (3)
Lead sponsors (1)
Conditions (2)
- Colorectal cancer Primary condition
- Colorectal neoplasm