A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
Part of paid clinical trials in Grand Rapids, Michigan.
- Sponsor
- ModernaTX, Inc.
- Study ID
- NCT06880549
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- mRNA-4106 — BIOLOGICALIntramuscular injection
- Pembrolizumab — BIOLOGICALIntravenous infusion
- mRNA-4200 — BIOLOGICALIntramuscular injection
Study Details
The purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.
Key Dates
- Start date
- Mar 25, 2025
- Status verified
- May 2026
- Primary completion
- Aug 3, 2027
- Completion
- Aug 3, 2027
Study Design
- Enrollment
- 42 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1 (Dose Escalation): mRNA-4106 AloneParticipants will receive mRNA-4106 at a test dose as monotherapy.
- Experimental: Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with PembrolizumabParticipants will receive mRNA-4200 as monotherapy, followed by mRNA-4200 in combination with pembrolizumab, and continuation of pembrolizumab alone.
Primary Outcome Measure
Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: For Arm 1: Days 1-21 and Arm 2: Days 1-42 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| START Midwest | Grand Rapids | Michigan | 49546 | - |
| START San Antonio | San Antonio | Texas | 78229 | - |
| START Mountain Region | West Valley City | Utah | 84119 | - |
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