Study on IMM-1-104 for Patients with Previously Treated Advanced or Metastatic Solid Tumors with RAS Mutation

Sponsor: Immuneering Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05585320

Provider View

This clinical trial is testing a new drug, IMM-1-104, to see if it is safe and effective in treating advanced or metastatic solid tumors with RAS mutations. The study will explore different doses and combinations with other approved treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called IMM-1-104 in patients with advanced or metastatic solid tumors that have a specific genetic mutation known as RAS. The study will test different doses of IMM-1-104, both on its own and in combination with other approved cancer treatments, to find the best dose for future research. Participants will be monitored to see how well the drug works in shrinking tumors and its effects on the body.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of an advanced or metastatic solid tumor with a RAS mutation.
    • For Phase 1: Any advanced solid tumor with a RAS mutation.
    • For Phase 2a: Specific cancers like pancreatic cancer, RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer.
    • For combination therapy: Advanced pancreatic cancer.
  • Must have received previous standard cancer treatments, except for certain cases:
    • For Phase 1: At least one prior treatment for advanced cancer.
    • For Phase 2a:
      • Pancreatic cancer: No prior treatment for first-line, one prior treatment for second-line.
      • Melanoma: No prior treatment for first-line, one or two prior treatments for second or third-line.
      • Lung cancer: One or two prior treatments.
    • For combination therapy: No prior treatment for advanced pancreatic cancer.
  • Must have measurable disease according to specific criteria.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate organ function.

Exclusion Criteria

  • Cannot swallow pills.
  • Have untreated or worsening brain metastases.
  • Have a history of certain eye conditions affecting the retina.
  • Have significant heart problems.
  • Have had muscle breakdown (rhabdomyolysis) recently.
  • Have an active skin condition needing treatment.
  • Women who are pregnant, breastfeeding, or planning to become pregnant, and men planning to father a child during the study.

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