Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Peter Vu, MD (ucsd)

Description

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.

Official Title

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

Keywords

Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC), pan-RAS, KRAS, NRAS, HRAS, Targeted therapy, Metastatic cancer, Advanced cancer, RAS, Adenocarcinoma, MEK, Dual MEK, MEK 1/2, Mitogen-Activated Protein Kinase (MAPK), G12A, G12C, G12D, G12F, G12R, G12S, G12V, G13C, G13D, G13R, Q61H, Q61K, Q61L, Q61R, A146T, A146V, K117N, Melanoma, Paclitaxel, Gemcitabine, Pembrolizumab, Dabrafenib, Folfirinox, 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)

Eligibility

Locations

  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Peter Vu, MD (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 7 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immuneering Corporation
ID
NCT05585320
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 320 study participants
Last Updated