A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors (NCT07071090) | Clinical Trial Compass
RecruitingPhase 1
A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
China32 participantsStarted 2025-06-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily signs the informed consent form, demonstrates understanding of the study, and is willing and able to comply with all trial procedures.
✓. Age ≥18 years, regardless of gender.
✓. 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.
✓. 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).
✓. 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 availability of a prior NGS report (within 3 years) confirming MTAP homozygous deletion or an IHC report confirming loss of MTAP expression, as accepted by the investigator.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Life expectancy ≥3 months.
✓. Absence of severe hematological, hepatic, renal, coagulation, or cardiac dysfunction.
Exclusion criteria
✕. Received chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, including: nitrosoureas or mitomycin C within 6 weeks prior; oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is shorter); Chinese herbal medicines with antitumor indications within 2 weeks prior.
✕. Received any non-marketed investigational drugs or therapies within 4 weeks prior to the first dose.
✕. Undergone major organ surgery (excluding needle biopsy or surgery for pathologic fractures), significant trauma, or planned elective surgery during the trial within 4 weeks prior.
✕. Used CYP3A4-sensitive substrates, strong inhibitors/inducers, CYP2C8-sensitive substrates, or P-gp inhibitors (see Appendix 3) within 14 days or 5 half-lives (whichever is shorter) prior.
✕. Previously treated with PRMT5 or MAT2A inhibitors.
✕. QTc interval ≥480 ms (mean of 3 measurements) on screening/baseline 12-lead ECG.
✕. Prior allogeneic hematopoietic stem cell/bone marrow transplantation or solid organ transplantation, or current use of immunosuppressants/anti-rejection drugs.
✕. Known allergy to any active/inactive ingredient of the study drug.