Study on the Safety and Effectiveness of TNG462 Combination Therapy in Pancreatic and Lung Cancer Patients

Sponsor: Tango Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06922591

This clinical trial is testing a new treatment using the drug TNG462 combined with either RMC-6236 or RMC-9805 to see if it is safe and effective for patients with certain types of pancreatic and lung cancer.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new oral treatment, TNG462, when used in combination with either RMC-6236 or RMC-9805. It is designed for patients with specific genetic changes in their pancreatic or lung cancer. The trial will be conducted in two phases: the first phase will determine the best dose, and the second phase will expand the study to more patients to further assess the treatment's effects.

Description

This clinical trial is exploring a new treatment for patients with advanced pancreatic or lung cancer that have specific genetic changes. The study involves taking an oral medication called TNG462, combined with either RMC-6236 or RMC-9805. The trial is divided into two parts: Phase 1, which focuses on finding the safest and most effective dose, and Phase 2, which involves more patients to better understand how well the treatment works. Participants will be monitored for safety, how well they tolerate the treatment, and any effects on their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a tumor with a specific genetic change called MTAP loss or RAS mutation.
  • Have advanced pancreatic cancer or lung cancer that has spread or cannot be removed by surgery.
  • Have received previous standard treatments for their cancer.
  • Must not have received previous treatments targeting RAS mutations.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have good organ function as determined by specific tests.
  • Must be able to swallow tablets.
  • Women must have a negative pregnancy test before starting the study.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Have received previous treatments with specific inhibitors related to the study drugs.
  • Have participated in previous trials of RMC-6236 or RMC-9805.
  • Have allergies or intolerances to the study drugs or their ingredients.
  • Have uncontrolled illnesses that would interfere with the study.
  • Have active infections requiring treatment.
  • Are participating in another clinical trial or plan to do so.
  • Have digestive issues that affect medication absorption.
  • Have untreated or worsening brain metastases.
  • Have active liver disease.
  • Are HIV positive unless specific health criteria are met.
  • Have significant heart disease.
  • Have lung diseases like interstitial lung disease.
  • Are pregnant or breastfeeding.
  • Are unable or unwilling to follow the study schedule and procedures.
  • Have other significant health issues that could affect safety or study results.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic Scottsdale85259-5452ScottsdaleArizona
Sarah Cannon Research Institute Denver80218DenverColorado
Mayo Clinic Jacksonville32224JacksonvilleFlorida
University of Indiana46202IndianapolisIndiana
Dana-Farber Cancer Institute02115BostonMassachusetts
Mayo Clinic Cancer Center55905-0001RochesterMinnesota
Nebraska Cancer Specialists68124OmahaNebraska
NYU Langone Health10016New YorkNew York
Memorial Sloan Kettering Cancer Center11065New YorkNew York
University of Texas MD Anderson Cancer Center77030HoustonTexas

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