A Phase 1, Open-label, Multicenter, Dose-escalation Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
ModernaTX, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Arm 1: Histologically confirmed advanced or metastatic cancer (melanoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal carcinoma, head and neck squamous cell carcinoma (HNSCC), urinary bladder cancer (UBC), colon/rectal adenocarcinomas, gastric, ovarian, cervical, and endometrial carcinomas) with measurable disease as determined by Response Evaluation Criteria In Solid Tumors volume 1.1 (RECIST v1.1) and have completed or refused all standard therapies (no limit to prior lines of therapy). Participants must have a tumor lesion amenabl…
Interventions
- BiologicalmRNA-4106
Intramuscular injection
- BiologicalPembrolizumab
Intravenous infusion
- BiologicalmRNA-4200
Intramuscular injection
Locations (4)
- START Los AngelesLos Angeles, California
- START MidwestGrand Rapids, Michigan
- START San AntonioSan Antonio, Texas
- START Mountain RegionWest Valley City, Utah