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

Detailed criteria

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

Biological
mRNA-4106
Intramuscular injection
Biological
Pembrolizumab
Intravenous infusion
Biological
mRNA-4200
Intramuscular injection

Locations (4)

START Los Angeles
Los Angeles, California
START Midwest
Grand Rapids, Michigan
START San Antonio
San Antonio, Texas
START Mountain Region
West Valley City, Utah

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

Summary

Eligibility

Interventions

Locations (4)

Compensation

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Details

Conditions