A Study of APG-3288 in Relapsed/Refractory Blood Cancers
brief summary
This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients with relapsed/refractory (R/R) hematologic malignancies.
detailed description
Part 1 (Dose Escalation Phase): Patients will receive orally administered APG-3288 at specified doses once daily in 28-day cycles. This phase aims to determine the MTD or RP2D of APG-3288 for patients who have failed standard therapy and for whom no standard therapy offering clinical benefit is available.
Part 2 (Dose Expansion Phase): Following the completion of Part 1, Part 2 will be initiated to further evaluate dose safety. Doses will be determined based on a comprehensive assessment of the pharmacokinetic (PK), pharmacodynamic (PD), safety, and efficacy data of APG-3288 from Part 1. In Part 2, up to 60 patients per chosen indication will be enrolled and randomly assigned in equal proportions to 2 or 3 dose cohorts to evaluate dose safety.
official title
A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of APG-3288 in Patients With Relapsed/Refractory Hematological Malignancies