Not Yet RecruitingPhase 1

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

United States, China180 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. New York Heart Association class III or IV cardiac disease, including pre-existing uncontrolled, clinically-significant arrhythmia, congestive heart failure, or cardiomyopathy.
✕. Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment.
✕. History of left ventricular ejection fraction \< 50%.
✕. Poorly controlled hypertension, or history of poor compliance with antihypertensive drug regimens.

What they're measuring

Incidence of dose-limiting toxicities (DLTs) at each dose level

Timeframe: From first dose through the end of Cycle 1 (e.g., Day 1 to Day 28)

Incidence of treatment emergent adverse events (TEAEs)

Timeframe: From first dose of study treatment through 30 days after the last dose

Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of APG 3288

Timeframe: During the dose escalation phase (Part 1)

Trial details

NCT IDNCT07424833

SponsorAscentage Pharma Group Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Yifan Zhai, M.D., Ph.D.

18998334688 Yzhai@ascentage.com

View on ClinicalTrials.gov More Relapsed/Refractory Hematological Malignancies trials