A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)
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
- Mocertatug rezetecan — DRUGMocertatug rezetecan will be administered
Study Details
The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez change over time at different dose amount
Key Dates
- First listed
- May 28, 2024
- Start date
- Jul 2, 2024
- Status verified
- Jun 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) |
Find similar trials in Birmingham, AL
Related Studies
- Novel Serum Markers for Monitoring Response to Anti-Cancer TherapyRecruiting · Stanford University · Stanford, California
- Collection of Tissue Samples for Cancer ResearchRecruiting · National Cancer Institute (NCI) · Atlanta, Georgia
- A Study Using White Blood Cells From Healthy Donors To Treat Solid CancersPHASE1/PHASE2 · Enrolling By Invitation · Dipnarine Maharaj · Boynton Beach, Florida
- CIBMTR Research DatabaseRecruiting · Center for International Blood and Marrow Transplant Research · Minneapolis, Minnesota