Study on Mirdametinib and BGB-3245 for Advanced Solid Tumors

Sponsor: SpringWorks Therapeutics, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05580770

This clinical trial is testing a combination of two drugs, Mirdametinib and BGB-3245, to see if they are safe and effective in treating adults with advanced solid tumors that have not responded to previous treatments or for which no other treatment options are available.

Patient Parameters

Program Overview

This study is exploring a new treatment using two drugs, Mirdametinib and BGB-3245, for adults with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body. The trial aims to find the right dose and see how well the treatment works in patients whose cancer has not improved with previous therapies like chemotherapy or immunotherapy, or who cannot tolerate standard treatments.

Eligibility Criteria

Inclusion Criteria

  • Be able to understand and agree to the study by signing a consent form.
  • Be at least 18 years old.
  • Have advanced solid cancer that has not improved with previous treatments or for which no other treatment is available.
  • For Part 1: Have a specific genetic change in the MAPK pathway.
  • For Part 2: Have specific genetic changes, such as:
    • Cohort A: Melanoma with NRAS mutations.
    • Cohort B: Non-small cell lung cancer (NSCLC) with KRAS mutations.
    • Cohort C: NSCLC or melanoma with certain BRAF mutations.
  • Provide a previous tumor sample or agree to a new biopsy.
  • Have measurable cancer according to standard criteria.
  • Be in good overall health with a performance status of 2 or less.
  • Have good organ function and no recent blood transfusions.

Exclusion Criteria

  • Have cancer that has spread to the brain or spinal cord.
  • Have a history of glaucoma.
  • Have an active parathyroid disorder or high calcium levels due to cancer.
  • Have had serious heart problems in the past 6 months.
  • Have had severe side effects from similar cancer treatments.
  • Have a serious or uncontrolled illness.
  • Cannot swallow pills.
  • Have an active infection like HIV, Hepatitis B, or C.
  • Have a history of bleeding disorders.
  • Have other medical conditions that make participation unsafe.
  • Have had major surgery or a serious injury in the past 4 weeks.
  • Have had cancer treatment in the past 2 weeks.
  • Are taking certain medications that affect the liver or immune system.
  • Have received a live vaccine in the past 4 weeks.

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