Clinical Trial

A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated September 2, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 candidate optimal dose of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in multiple Phase 2a proof-of-concept cohorts in malignancies of interest.
Protocol Amendment History 29 amendments
This ClinicalTrials.gov record has been amended 29 times since 2022-10-14; most recent amendment 2025-08-29.
Status change: Recruiting → Active, Not Recruiting 2025-08-29
Status change: Not Yet Recruiting → Recruiting 2022-10-21
Trial Details
NCT Number NCT05585320
Lead Sponsor Immuneering Corporation
Conditions Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC)
Enrollment 209 participants
Start Date 2022-10-31
Primary Completion 2026-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-02