Phase 1 Study of DC50292A Tablets for Safety and Effectiveness in Adults with MTAP-Deleted Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetic profile, and early effects of DC50292A tablets in patients with MTAP-deficient advanced or metastatic solid tumors. This open-label, non-randomized Phase I study aims to find the best dose and gather initial efficacy data. The trial is sponsored by Heronova Pharmaceuticals and includes two parts dose escalation and dose expansion phases. In the dose escalation phase, participants receive increasing doses of DC50292A tablets starting from 40 mg up to 900 mg, with study groups planned for six dose levels. This phase includes a single dose followed by pharmacokinetic blood sampling and then daily dosing for three weeks with breaks for toxicity assessment. The dose expansion phase will follow to further evaluate two selected doses up to the maximum tolerated dose, with participants receiving daily oral treatment in 4-week cycles until stopping criteria are met. Participants will be closely monitored with blood samples taken for pharmacokinetic and pharmacodynamic analysis, along with safety assessments over 12 months. Researchers will track adverse events and measure tumor response and progression-free survival. Treatment may continue until disease progression, intolerable side effects, or other study-defined reasons. The total duration of follow-up and treatment varies depending on individual response and study phase.

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