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Phase 1/2Active, not recruiting

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

A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Sponsor
Immuneering Corporation (Industry)
Enrollment
209 enrolled
Conditions
Advanced Solid Tumor; Pancreatic Adenocarcinoma; Malignant Melanoma (Cutaneous); Non-small Cell Lung Cancer (NSCLC)
Interventions
IMM-1-104 Monotherapy (Treatment Group A); IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B); IMM-1-104 + modified FOLFIRINOX (Treatment Group C); IMM-1-104 + dabrafenib (Treatment Group D); IMM-1-104 + pembrolizumab (Treatment Group E)
Ages
adults, older adults
Registry
NCT05585320

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Phase 1: Adverse Events
  • Phase 1: Dose-Limiting Toxicities
  • Phase 1: Recommended Phase 2 Candidate Optimal Dose
  • Phase 2a: Overall Response Rate

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered