A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
NCT ID: NCT07071090
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
32 participants
INTERVENTIONAL
2025-06-30
2028-01-01
Brief Summary
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Detailed Description
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Each dose group will undergo: Single-dose administration (C0D1-C0D5): A single dose on C0D1, followed by PK blood sampling from C0D2 to C0D5.
Cycle 1 (C1D1-C1D21): Starting from C1D1 (after C0D5), subjects will receive daily dosing for 3 weeks, followed by a 3-day break (until C1D25 pre-dose) for dose-limiting toxicity (DLT) assessment, along with PK and pharmacodynamic (PD) sample collection and analysis. Subsequent cycles (C2D1-CnD28): Continuous dosing in subsequent cycles, with adjustments and optimizations based on cumulative safety, PK, and PD data. If no DLT-based stopping criteria are met during the observation period, the dose will escalate to the next level. After the DLT observation period, eligible subjects may continue treatment with DC50292A until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of consent, voluntary discontinuation, death, loss to follow-up, or other protocol-specified termination criteria-whichever occurs first. Dose Expansion Phase: after determining the maximum tolerated dose (MTD) in the escalation phase, two optimal doses (≤MTD) will be selected for expansion based on cumulative efficacy, safety, and PK data. Each expansion cohort will enroll 8 subjects, receiving oral DC50292A in an optimized regimen (tentatively once daily in 4-week cycles) until meeting discontinuation criteria (as above).
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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DC50292A
All enrolled subjects will receive DC50292A orally. Doses will be escalated from low to high：40 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg.
DC50292A
DC50292A tablet
Interventions
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DC50292A
DC50292A tablet
Eligibility Criteria
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Inclusion Criteria
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 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.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Life expectancy ≥3 months.
8. Absence of severe hematological, hepatic, renal, coagulation, or cardiac dysfunction.
9. Male and female participants of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Female participants of childbearing potential must have a negative serum pregnancy test result prior to the first dose of the study medication.
Exclusion Criteria
2. Received any non-marketed investigational drugs or therapies within 4 weeks prior to the first dose.
3. 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.
4. 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.
5. Previously treated with PRMT5 or MAT2A inhibitors.
6. QTc interval ≥480 ms (mean of 3 measurements) on screening/baseline 12-lead ECG.
7. Prior allogeneic hematopoietic stem cell/bone marrow transplantation or solid organ transplantation, or current use of immunosuppressants/anti-rejection drugs.
8. Known allergy to any active/inactive ingredient of the study drug.
9. Adverse reactions from prior antitumor therapy not resolved to CTCAE v5.0 Grade ≤1 (except non-risks like alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism on hormone replacement).
10. Hepatitis B (HBsAg+ with HBV-DNA ≥2500 copies/mL or 500 IU/mL), HCV (HCV-RNA \> lower limit of detection), HIV-positive, or syphilis (both specific/non-specific antibodies positive).
11. Symptomatic/active CNS metastases, leptomeningeal disease, or spinal cord compression. Asymptomatic CNS metastases may enroll if:
1. Measurable extracranial lesions per RECIST v1.1;
2. No new/progressive CNS lesions for ≥4 weeks with stable neurologic symptoms;
3. No seizures/increased intracranial pressure;
4. No steroids/antiepileptics/dehydrants for ≥2 weeks.
12. Clinically significant third-space fluid accumulation (e.g., massive ascites/pleural effusion).
13. Cardiovascular Disease: severe arrhythmias (e.g., ventricular arrhythmias requiring intervention, AV block II-III); ACS, CHF, aortic dissection, stroke, or Grade ≥3 cardiovascular events within 6 months; NYHA Class ≥II or high-risk structural heart disease; uncontrolled hypertension (SBP ≥150 mmHg and/or DBP ≥95 mmHg); QTc prolongation risks (e.g., heart failure, uncorrected hypokalemia, congenital/family history of long QT syndrome, concomitant QT-prolonging drugs).
14. Systemic treatment for active infection within 4 weeks prior.
15. Acute esophageal/GI diseases affecting drug absorption (e.g., bowel obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome).
16. Pulmonary Disease: interstitial lung disease (ILD), pulmonary fibrosis, or drug-induced pneumonitis requiring treatment.
17. Other Severe Conditions: hepatic, renal, neurologic/psychiatric, endocrine, hematologic, or immune disorders compromising study participation.
18. Other malignancies within 5 years (except cured malignancies like basal/ squamous cell skin cancer, low-risk prostate cancer, papillary thyroid cancer, or excised in situ cancers).
19. Known alcohol/drug dependence.
20. Psychiatric disorders or poor adherence.
21. Pregnant or breastfeeding women.
22. Investigator's Discretion: any other clinical/laboratory abnormalities deemed unsuitable for the study.
18 Years
ALL
No
Sponsors
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Heronova Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Shandong Cancer Hospital
Jinan, Shandong, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHRC-CRDC05-01-01
Identifier Type: -
Identifier Source: org_study_id
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