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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.