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Not Yet RecruitingNCT07424833

A Study of APG-3288 in Relapsed/Refractory Blood Cancers

A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of APG-3288 in Patients With Relapsed/Refractory Hematological Malignancies

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
Ascentage Pharma Group Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAPG-3288Orally administered daily; 28 days per cycle.

Timeline

Start date
2026-03-01
Primary completion
2029-12-01
Completion
2031-12-01
First posted
2026-02-20
Last updated
2026-02-20

Locations

2 sites across 2 countries: United States, China

Regulatory

Source: ClinicalTrials.gov record NCT07424833. Inclusion in this directory is not an endorsement.