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drugset / Trial / NCT05585320

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

NCT05585320 ↗

Phase 1/2 Active not recruiting 209 enrolled Immuneering Corporation
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-10-31
Primary completion
2026-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject IMM-1-104 Unknown — Oral
Background Dabrafenib Small molecule 75 mg Oral
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Irinotecan Small molecule 150 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

cutaneous melanoma non-small cell lung carcinoma pancreatic adenocarcinoma