Study on IMM-6-415 for Treating Solid Tumors with RAS/RAF Mutations

Sponsor: Immuneering Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06208124

Provider View

This clinical trial is testing a new drug, IMM-6-415, to see if it is safe and effective in treating advanced solid tumors with specific genetic mutations. The study aims to find the best dose and understand how well the drug works against these tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called IMM-6-415 in patients with advanced or metastatic solid tumors that have specific genetic mutations in the RAS or RAF genes. The study will help determine the best dose of IMM-6-415 for future research and assess its ability to shrink tumors. Participants will take the drug daily for up to 16 cycles, with each cycle lasting 21 days. During the first two cycles, researchers will closely monitor how the drug is processed in the body and its effects on the tumors.

Description

This study is designed to find the best dose of IMM-6-415, a new drug being tested for its ability to treat solid tumors with RAS or RAF mutations. Participants will take the drug daily for up to 16 cycles, each lasting 21 days. The first two cycles will involve detailed monitoring to understand how the drug is absorbed and its initial effects on the tumors. The study is open to patients with various types of solid tumors that have these specific genetic mutations, including pancreatic cancer, melanoma, and certain lung and gastrointestinal cancers. Participants must have already tried at least one standard treatment for their cancer and be considered unlikely to benefit from other available options. The study will also include patients who have previously been treated with specific inhibitors targeting the KRAS mutation.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a life expectancy of more than 16 weeks.
  • Have a confirmed diagnosis of an advanced solid tumor with RAS or RAF mutations, based on genetic testing.
  • Have tried at least one standard treatment for their cancer and are unlikely to benefit from other treatments.
  • Have measurable disease according to specific medical criteria.
  • Have a performance status indicating they are fully active or have some restrictions but can still perform light work.
  • Have adequate organ function as determined by medical tests.

Exclusion Criteria

  • Cannot swallow pills.
  • Have untreated or worsening cancer that has spread to the brain.
  • Have uncontrolled fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
  • Have ongoing severe COVID-19 symptoms requiring oxygen therapy.
  • Have unresolved side effects from previous cancer treatments.
  • Have significant heart problems or other serious medical conditions.
  • Have a history of eye conditions affecting the retina.
  • Have had muscle breakdown (rhabdomyolysis) recently.
  • Have HIV but are not on stable treatment.
  • Have a history of hepatitis B or C but are not currently requiring treatment or have an undetectable viral load.
  • Are pregnant, breastfeeding, or planning to become pregnant, or are men planning to father a child during the study.

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