A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Trial Parameters
Brief Summary
This study employs a non-randomized, open-label design to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of DC50292A tablets in patients with MTAP-deficient advanced or metastatic solid tumors. The study consists of two parts: dose escalation and dose expansion.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily signs the informed consent form, demonstrates understanding of the study, and is willing and able to comply with all trial procedures. 2. Age ≥18 years, regardless of gender. 3. Patients with histologically and/or cytologically confirmed solid tumors who are assessed by the investigator as having locally advanced, recurrent, or metastatic disease and have failed standard treatments at the current stage. 4. At least one measurable lesion as per RECIST v1.1 criteria, assessed via imaging (tumor lesions located in previously irradiated areas or those having undergone other local-regional therapies are generally not considered measurable unless clear progression is confirmed by the investigator). 5. MTAP deficiency, defined by one of the following: willingness to provide sufficient archived tumor tissue or fresh biopsy samples for MTAP testing; or documentation of MTAP homozygous deletion via NGS/IHC or loss of MTAP protein expression in tissue; or availa