Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT07077434
Eligibility Criteria:
Inclusion Criteria:
* Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
* Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.
Exclusion Criteria:
* Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.
* Participants must not have active brain metastases or carcinomatous meningitis.
* Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07077434
Study Brief:
Protocol Section:
NCT07077434