Phase IIIa Study of AD1208, a Cell Cycle and MASTL Inhibitor, Alone or With Other Treatments in Adults With Progressive, Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of AD1208, a cell cycle inhibitorMASTL inhibitor, in adults with any progressive, locally advanced unresectable or metastatic solid tumors. This phase IIIa trial aims to find the maximum tolerated dose or maximum administered dose of AD1208 and to understand the medical issues participants may experience while taking this drug. The study addresses important questions about which dosage is safe and how participants tolerate the treatment. AD1208 is given orally once or twice daily in 21-day treatment cycles. The trial includes a dose-escalation phase divided into phase 1a for monotherapy dose recommendation and phase 1b for combination therapy dose recommendation. Participants may receive one of several doses ranging from 40 mg twice daily up to 340 mg twice daily. During the first cycle, participants visit the study site weekly for checkups and tests, then every three weeks from the second cycle onward. Participants will also keep a diary to record any adverse events and drug administration. Participants will be involved in regular assessments including laboratory tests to check blood, liver, and kidney function before and during treatment. Researchers will monitor safety and tolerability at the end of the first 21-day cycle. Additional measures include drug concentrations in the blood at specific times during cycle 1 and ongoing evaluations of tumor response and disease progression for approximately one year. The study includes careful monitoring of treatment duration, disease control, and survival outcomes until study completion.

AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors