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 — BIOLOGICAL
    Intramuscular injection
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion
  • mRNA-4200 — BIOLOGICAL
    Intramuscular 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 Alone
    Participants will receive mRNA-4106 at a test dose as monotherapy.
  • Experimental: Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab
    Participants 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)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546-
START San AntonioSan AntonioTexas78229-
START Mountain RegionWest Valley CityUtah84119-

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