NCT07071090

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

An Open-Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Heronova Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Dose Escalation Phase: The dose escalation study will first be conducted using an accelerated titration "3+3" design, progressing from lower to higher dose levels. Six dose groups are planned: 40 mg, 100 mg, 200 mg, 400 mg, 600 mg, and 900 mg (subject to adjustment based on study results, such as adding intermediate dose levels). The 40 mg group will follow an accelerated titration design, enrolling 1-6 subjects, while the 100-900 mg groups will enroll 3-6 subjects per cohort. 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

• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	DC50292A	DC50292A tablet

Timeline

• Start date: 2025-06-30
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-07-17
• Last updated: 2025-07-23

Locations

8 sites across 1 country: China