A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumor Malignancies

In brief

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.

Key facts

Study ID

NCT07071090

Run by

Heronova Pharmaceuticals

People needed

32

Starts

2025-06-30

Expected to finish

2028-01-01

Last updated by the study team

2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.
• 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).
• 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).
• 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.
• Clinically significant third-space fluid accumulation (e.g., massive ascites/pleural effusion).
• 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).
• Systemic treatment for active infection within 4 weeks prior.
• Acute esophageal/GI diseases affecting drug absorption (e.g., bowel obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome).
• Pulmonary Disease: interstitial lung disease (ILD), pulmonary fibrosis, or drug-induced pneumonitis requiring treatment.
• Other Severe Conditions: hepatic, renal, neurologic/psychiatric, endocrine, hematologic, or immune disorders compromising study participation.
• 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).
• Known alcohol/drug dependence.
• Psychiatric disorders or poor adherence.
• Pregnant or breastfeeding women.

Where it is running

• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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