Study on ELI-002 7P for Patients with KRAS/NRAS Mutated Solid Tumors

Sponsor: Elicio Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05726864

Provider View

This clinical trial is testing a new immunotherapy treatment called ELI-002 7P for patients with solid tumors that have specific KRAS or NRAS mutations. The study aims to determine if this treatment is safe and effective in preventing cancer from returning after initial treatments.

Patient Parameters

Program Overview

The study is investigating a new treatment, ELI-002 7P, for patients with solid tumors that have mutations in the KRAS or NRAS genes. This treatment combines immune-stimulating substances with specific proteins to help the body fight cancer. The study is divided into three phases to evaluate the safety and effectiveness of the treatment in preventing cancer recurrence.

Description

The study is divided into three phases:

  • Phase 1A: This phase tests different doses of ELI-002 7P in small groups of patients to find the best dose for further testing. The treatment includes a combination of immune-stimulating substances and proteins targeting specific KRAS and NRAS mutations.

  • Phase 1B: This phase may include up to 17 patients with colorectal cancer to see if the treatment can reduce cancer markers in the blood, which are indicators of cancer activity.

  • Phase 2: In this phase, 135 patients with pancreatic cancer will be randomly assigned to receive either the ELI-002 7P treatment or be observed without treatment. Those receiving the treatment will get injections under the skin during specific periods. Patients in the observation group will have the same health checks but will not receive the treatment. If their cancer progresses, they can choose to start the ELI-002 7P treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a solid tumor with specific KRAS or NRAS mutations (G12D, G12R, G12V, G12A, G12C, G12S, G13D).
  • For Phase 1 only: Show signs of cancer in the blood despite previous treatments like surgery or chemotherapy.
  • No signs of cancer returning on a CT scan.
  • Be in good overall health, able to carry out normal activities or light work.

Exclusion Criteria

  • Have tumor mutations that already have approved treatments.
  • Have known cancer spread to the brain.
  • Be using drugs that suppress the immune system.

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