Study on AMG 193 for Adults with Advanced MTAP-null Solid Tumors

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05094336

This clinical trial is testing the safety and effectiveness of a new drug, AMG 193, alone and in combination with another drug, docetaxel, in adults with advanced solid tumors that lack a specific enzyme called MTAP.

Patient Parameters

Program Overview

The study aims to find out if AMG 193, either by itself or with docetaxel, is safe and can be tolerated by adults with advanced solid tumors that are missing the MTAP enzyme. It also seeks to determine the best dose for future studies. In the later part of the study, researchers will evaluate how well AMG 193 works in shrinking these tumors.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a specific genetic change in the tumor, either in the CDKN2A or MTAP genes.
  • Must have a confirmed diagnosis of advanced solid tumor that cannot be cured with surgery or radiation.
  • Must be able to swallow pills and willing to keep track of taking the study medication daily.
  • Must have measurable disease according to specific medical criteria.
  • Must be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate blood, kidney, liver, and heart function as determined by lab tests.
  • Must have a life expectancy of at least 12 weeks.
  • Must provide a sample of tumor tissue collected within the last 5 years.
  • For certain parts of the study, must be willing to undergo a tumor biopsy.
  • For specific parts of the study, must be willing to eat a high-fat meal or fast for a certain period.
  • For participants with glioma, must have measurable disease according to specific criteria.

Exclusion Criteria

  • Have untreated or active cancer spread to the brain or spinal cord.
  • Have had another type of cancer within the last 2 years.
  • Have lung disease or active infections.
  • Have a history of heart attack or heart failure.
  • Have digestive tract diseases or history of bowel obstruction.
  • Have had a solid organ transplant.
  • Have had major surgery recently.
  • Have received anti-cancer treatment within the last 28 days.
  • Have received certain types of cancer treatments before.
  • Have received radiation therapy recently.
  • Have received a live vaccine recently.
  • Are taking certain medications that affect liver enzymes.
  • Have unresolved side effects from previous cancer treatments.
  • Are participating in another clinical trial.
  • Have tested positive for HIV, hepatitis B, or hepatitis C.
  • Female participants of childbearing potential must agree to use effective contraception.

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