Actively Recruiting
A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Led by Heronova Pharmaceuticals · Updated on 2025-07-23
32
Participants Needed
8
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- 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.
You will not qualify if you...
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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.
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Received any non-marketed investigational drugs or therapies within 4 weeks prior to the first dose.
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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.
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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.
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Previously treated with PRMT5 or MAT2A inhibitors.
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QTc interval ≥480 ms (mean of 3 measurements) on screening/baseline 12-lead ECG.
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Prior allogeneic hematopoietic stem cell/bone marrow transplantation or solid organ transplantation, or current use of immunosuppressants/anti-rejection drugs.
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Known allergy to any active/inactive ingredient of the study drug.
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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).
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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).
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Symptomatic/active CNS metastases, leptomeningeal disease, or spinal cord compression. Asymptomatic CNS metastases may enroll if:
- Measurable extracranial lesions per RECIST v1.1;
- No new/progressive CNS lesions for ≥4 weeks with stable neurologic symptoms;
- No seizures/increased intracranial pressure;
- No steroids/antiepileptics/dehydrants for ≥2 weeks.
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Clinically significant third-space fluid accumulation (e.g., massive ascites/pleural effusion).
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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).
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Systemic treatment for active infection within 4 weeks prior.
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Acute esophageal/GI diseases affecting drug absorption (e.g., bowel obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome).
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Pulmonary Disease: interstitial lung disease (ILD), pulmonary fibrosis, or drug-induced pneumonitis requiring treatment.
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Other Severe Conditions: hepatic, renal, neurologic/psychiatric, endocrine, hematologic, or immune disorders compromising study participation.
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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).
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Known alcohol/drug dependence.
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Psychiatric disorders or poor adherence.
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Pregnant or breastfeeding women.
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Investigator's Discretion: any other clinical/laboratory abnormalities deemed unsuitable for the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
3
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
7
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
8
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
K
Kang Ren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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