Phase I/II Trial of Navlimetostat with Pumitamig for Advanced Non-Small Cell Lung Cancer with MTAP Deficiency

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07579221

Provider View

This study is testing a new treatment combination of navlimetostat and pumitamig to find a safe dose and see how well it works for patients with advanced non-small cell lung cancer (NSCLC) that lacks a specific protein called MTAP.

Patient Parameters

Program Overview

The purpose of this clinical trial is to determine a safe and tolerable dose of navlimetostat combined with pumitamig for patients with advanced non-small cell lung cancer (NSCLC) that is missing the MTAP protein. The study will also evaluate how effective these drugs are in treating the cancer.

Description

This study is divided into two phases. In Phase I, the focus is on finding a safe dose of navlimetostat and pumitamig. In Phase II, researchers will look at how well the treatment works in controlling the cancer. They will also monitor side effects and how well patients tolerate the treatment.

The study will measure outcomes like how long the cancer is controlled, how long patients live without the cancer getting worse, and overall survival. Researchers will compare results between patients who have had previous immune therapy and those who have not.

Additionally, the study will explore potential markers that might predict how well patients respond to the treatment, such as changes in certain proteins or immune cells in the blood.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have at least one measurable tumor that can be tracked.
  • Cancer must lack the MTAP protein, confirmed by specific tests.
  • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Must have received at least one prior treatment for advanced cancer.
  • Must have good organ function and blood counts.
  • Must agree to follow the study protocol, including visits and tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use condoms during sexual activity and not donate sperm during the study and for six months after.

Exclusion Criteria

  • Previous treatment with similar drugs targeting PRMT5 or MAT2A.
  • Recent treatment with certain cancer therapies.
  • High risk of bleeding in the lungs or other major organs.
  • Recent history of significant bleeding or blood vessel issues.
  • Uncontrolled high blood pressure or diabetes.
  • Other active cancers requiring treatment.
  • Major surgery within the last 21 days.
  • Heart rhythm issues or other serious medical conditions.
  • Untreated brain metastases or certain infections.
  • Pregnant or breastfeeding women.
  • Use of certain medications that interact with the study drugs.
  • Active hepatitis or HIV with certain conditions.
  • Recent use of live vaccines or certain herbal supplements.
  • History of severe allergic reactions to similar treatments.
  • Active autoimmune diseases requiring treatment.

Locations

FACILITYZIPCITYSTATE
UT MD Anderson77090HoustonTexas

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