A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed
Part of paid clinical trials in Los Alamitos, California.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT06885034
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Gastrointestinal Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GSK5764227 — BIOLOGICALGSK5764227 will be administered
Study Details
This study will check how well a new medicine, GSK5764227, works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.
Key Dates
- First listed
- Mar 19, 2025
- Start date
- Jun 11, 2025
- Status verified
- Jul 2026
- Primary completion
- Jan 10, 2028
- Completion
- Jan 9, 2029
Study Design
- Enrollment
- 451 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CRC-A: GSK5764227 (Dose 1)
- Experimental: CRC-A: GSK5764227 (Dose 2)
- Experimental: CRC-B: GSK5764227 (Dose 3)
- Experimental: CRC-B: GSK5764227 (Dose 4)
- Experimental: PDAC: GSK5764227 (Dose 5)
Primary Outcome Measure
Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 22 months ]
Central Contacts
- US GSK Clinical Trials Call Center877-379-3718
- EU GSK Clinical Trials Call Center+44 (0) 20 89904466
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Los Alamitos | California | 90505 | Vu Phan (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Los Angeles | California | 90089 | Heinz-Josef Lenz (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Santa Monica | California | 90404 | J. Randolph Hecht (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Whittier | California | 90602 | Andrew Pham (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Aurora | Colorado | 80045 | Hannah Robinson (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | New York | New York | 10021 | Rutika Mehta (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | New York | New York | 10065 | Andrea Cercek (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Durham | North Carolina | 27710 | Nicholas Devito (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Houston | Texas | 77479 | Kanwal Raghav (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | San Antonio | Texas | 78229 | Drew Rasco (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Wenatchee | Washington | 98801 | Lindsay Overton (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Madison | Wisconsin | 53792-0001 | Dustin Deming (PRINCIPAL_INVESTIGATOR) |
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