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

NCT07071090 | Recruiting Phase 1

• 1 other identifier: SHRC-CRDC05-01-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Incidence and severity of adverse events as assessed by CTCAE Version 5.0

  12 months

Secondary Outcomes (7)

• PK profile of DC50292A

  From time zero up to 96 hours post-dose

• PK profile of DC50292A

  From time zero up to 96 hours post-dose

• PK profile of DC50292A

  From time zero up to 96 hours post-dose

• PK profile of DC50292A

  From time zero up to 96 hours post-dose

• PK profile of DC50292A

  From time zero up to 96 hours post-dose

Study Arms (1)

DC50292A

EXPERIMENTAL

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.

Drug: DC50292A

Interventions

DC50292A DRUG

DC50292A tablet

DC50292A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Heronova Pharmaceuticals: lead

Study Sites (8)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Kang Ren

CONTACT

+86-13269683867; renkang@dcpc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)