A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT06431594
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Neoplasms
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GSK5733584 — DRUGGSK5733584 will be administered
Study Details
The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.
Key Dates
- Start date
- Jul 2, 2024
- Status verified
- May 2026
- Primary completion
- Sep 22, 2027
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 675 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1: Dose EscalationParticipants with advanced solid tumors who are refractory or intolerant to established standard therapies
- Experimental: Part 2: Dose ExpansionParticipants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)
Primary Outcome Measure
Part 1: Number of participants with dose limiting toxicity (DLT) [ Time Frame: Up to 21 days ]
Central Contacts
- US GSK Clinical Trials Call Center877-379-3718
- EU GSK Clinical Trials Call Center+44 (0) 20 89904466
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | Charles Leath (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Fountain Valley | California | 92708 | Amol Rao (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Santa Rosa | California | 95403 | Ian Anderson (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Lake Mary | Florida | 32746 | - |
| GSK Investigational Site | Orlando | Florida | 32827 | Cesar Perez Batista (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Fairway | Kansas | 66205 | Andrea Jewell (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Boston | Massachusetts | 02114 | Sara Bouberhan (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Boston | Massachusetts | 02215 | Elizabeth Lee (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Detroit | Michigan | 48201 | Ira Winer (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Grand Rapids | Michigan | 49546 | Nehal Lakhani (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | Deanna Teoh (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Mineola | New York | 11501 | Bhavana Pothuri (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | New York | New York | 10016 | Bhavana Pothuri (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Portland | Oregon | 97213 | Christopher Darus (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Nashville | Tennessee | 37203 | Denise Yardley (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Dallas | Texas | 75230 | Reva Schneider (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | West Valley City | Utah | 84119 | William McKean (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Seattle | Washington | 98104 | Fernanda Musa (PRINCIPAL_INVESTIGATOR) |
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