Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Peter Vu, MD

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 dose (RP2D) 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 Previously Treated RAS-Mutated 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, 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)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must be ≥18 years of age
  • Must have histologically or cytologically confirmed diagnosis as follows:
    1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
    2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC)
    3. Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC
  • Participants must be treatment naive or received prior systemic standard-of-care treatment as follows:
    1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease
    2. Monotherapy Phase 2a:
      1. First-line PDAC participants will have received no previous systemic anti-cancer therapy. Second-line PDAC participants will have received no more than one prior systemic anti-cancer therapy.
      2. First-line melanoma participants will have received no previous systemic anti-cancer therapy. Second- and third-line participants will have received and failed one or two prior systemic anti-cancer therapies, respectively.
      3. NSCLC participants will have received at least one and no more than two previous lines of systemic therapy.
    3. Combination therapy (both phases): PDAC participants will have received no previous systemic anti-cancer therapy for their advanced or metastatic disease.
  • Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

You CAN'T join if...

  • Inability to swallow oral medications
  • Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases
  • History or concurrent evidence of retinal vein occlusion (RVO) or current risk factors for RVO. History of serous retinopathy, retinal edema, or retinal pigment epithelial detachment (RPED)
  • Impaired cardiovascular function or clinically significant cardiac disease
  • History of rhabdomyolysis within 3 months prior to start of study treatment
  • Active skin disorder requiring systemic treatment within 3 months prior to the start of study treatment
  • Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

Locations

  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCSD

  • Peter Vu, MD
    Assistant 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 210 study participants
Last Updated