About this trial
The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
Eligibility criteria
Qualifiers
Age ≥18 years.
All patients must have a histologically confirmed advanced or metastatic solid tumor that has been refractory to standard therapy or are not eligible for standard therapy and have no alternative curative-intent treatment options at the time of patient enrollment. For the dose escalation, any solid tumor is eligible, but enrollment will be enriched for CCA and pancreatic cancer. For the pharmacodynamic expansion, patients must have histologically confirmed advanced or metastatic CCA or pancreatic cancer.
Homozygous deletion of MTAP as detected by Clinical Laboratory Improvement Amendmentscertified next-generation sequencing test or absence of MTAP protein as detected by CLIAcertified immunohistochemistry test.
Patients in Part A must have archived tumor tissue available for retrospective analysis or agree to pre-treatment biopsy.
Disqualifiers
Part B only: Prior treatment with a PRMT5 or methionine adenosyltransferase 2A inhibitor.
Patients who have a known additional malignancy that is progressing or requires active treatment at time of study treatment initiation. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and/or complications prior to eligibility assessment.
Concomitant use of strong cytochrome P450 (CYP)3A inhibitors or inducers are prohibited within 14 days or 5 half-lives, whichever is longer, prior to study treatment initiation and during the study treatment period. For a comprehensive list of CYP3A inhibitors/inducers, refer to: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactionstable-substrates-inhibitors-and-inducers.
Trial design
Treatments tested in this trial
- MRTX1719
- Olaparib