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APG-3288 for Relapsed/Refractory Blood Cancers

This study is testing a new oral medication called APG-3288 for people with certain blood cancers that have come back or not responded to previous treatments (relapsed/refractory hematological malignancies). These include specific types of leukemia (CLL/SLL), lymphoma (DLBCL, MCL), and Waldenström Macroglobulinemia. APG-3288 works as a targeted therapy and immunotherapy. The main goal of this study is to find the safest and most effective dose of APG-3288. You might be able to join if you are 18 or older, have one of these blood cancers, and meet other health requirements. The study is currently unclear about its recruitment status.

Study design
This is a Phase 1, open-label study with an estimated 180 participants. It has two parts: a dose escalation phase to find the right dose, and a dose expansion phase to further check safety.
What's involved
You would take APG-3288 by mouth once daily, with each treatment cycle lasting 28 days. The study will monitor for side effects from the first dose through 30 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
The study measures side effects from the first dose through 30 days after the last dose of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07424833

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ascentage Pharma Group Inc.
~180 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:APG-3288

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs) at each dose level
Measured over From first dose through the end of Cycle 1 (e.g., Day 1 to Day 28)
+2 more outcomes measured

Conditions

Relapsed/Refractory Hematological Malignancies
Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation)
Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Relapsed/Refractory Waldenström Macroglobulinemia (WM)
Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Relapsed/Refractory Follicular Lymphoma (FL)

Explore related trials

Chronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular LymphomaHematologic NeoplasmMantle Cell LymphomaMarginal Zone LymphomaSmall Lymphocytic LymphomaWaldenstrom Macroglobulinemia

NCT07424833

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Henan Cancer Hospital

    Zhengzhou, Henan, Chinastudy coordinator listed

    Recruiting

  • Mayo Clinic

    Jacksonville, Floridano site contact published

    Not yet recruiting

  • START Los Angele

    Los Angeles, Californiano site contact published

    Recruiting

  • START Midwest

    Grand Rapids, Michiganno site contact published

    Recruiting

  • START New Jersey

    East Brunswick, New Jerseyno site contact published

    Recruiting

  • The University of TX MD Anderson Cancer Center

    Houston, Texasno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Keshu Zhou, M.D.,Ph.D. · PRINCIPAL_INVESTIGATOR · Henan Cancer Hospital

Who to contact

Yifan Zhai, M.D., Ph.D.
[email protected]
18998334688
Email the study team

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Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) status ≤ 1 in Part 1 (dose escalation), and ≤ 2 in Part 2 (dose expansion).
Part 1 (Dose Escalation): histologically or cytologically confirmed diagnosis of R/R CLL/SLL, DLBCL (including Richter Transformation), MCL, WM, MZL, or FL.
Prior systemic therapy: at least 2 prior lines of systemic therapy (including BTK inhibitor for approved indications) and who have failed or are not eligible for available therapies with established clinical benefit.
Measurable disease per response criteria specific to the malignant condition.
Adequate organ and bone marrow function.

Exclusion

Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with the exception of hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels).
Any investigational therapy within 14 days prior to the first dose of study drug or within 5 half-lives of the respective investigational drug (whichever is shorter).
Persistent toxicities from prior radiotherapy, targeted therapy, immunotherapy, or chemotherapy agents that have not recovered to Grade \<2 (except for alopecia or vitiligo).
Symptomatic brain metastases due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors who have been treated, are asymptomatic, and who have discontinued steroids (for the treatment of CNS tumors) for \> 28 days may be enrolled.
Use of therapeutic-dose anticoagulants or antiplatelet agents. (Use of low-dose anticoagulants to maintain central venous catheter patency is permitted)
Biological growth factors within 7 days prior to the first dose of study drug.
Patients who, in the investigator's judgment, have not adequately recovered from prior surgery, or have undergone major surgery within 28 days prior to enrollment, or minor surgery within 14 days prior to enrollment.
Significant cardiac disease defined as:
Clinically active and uncontrolled symptomatic infection; well-controlled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection may be considered for enrollment.
Autoimmune diseases, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
Concurrent use of QT-prolonging medications or history of torsades de pointes.
Concurrent malignancy other than the one being treated in this study with the exception of the following: cured malignancy without recurrence within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type.
Any severe and/or uncontrolled medical condition that, in the investigator's opinion, may compromise the individual's safety or the evaluation of study results.
Prior treatment with: BTK degrader treatment or allogeneic stem cell transplant

What this trial measures

  • Incidence of dose-limiting toxicities (DLTs) at each dose levelFrom first dose through the end of Cycle 1 (e.g., Day 1 to Day 28)

    A DLT is defined as any treatment-related adverse event (TRAE) meeting protocol-specified toxicity criteria occurring during the DLT evaluation period (Cycle 1). DLTs will be assessed in participants receiving escalating dose levels of APG-3288 to evaluate its safety and tolerability.

  • Incidence of treatment emergent adverse events (TEAEs)From first dose of study treatment through 30 days after the last dose

    The incidence of treatment emergent adverse events (TEAEs), including Grade 3-5 TEAEs, serious adverse events (SAEs), TEAEs leading to dose interruption, dose reduction, or treatment discontinuation, and deaths, will be assessed in participants receiving APG-3288 in Part 1 (dose escalation) and Part 2 (dose expansion) of the study.

  • Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of APG 3288During the dose escalation phase (Part 1)

    The MTD and/or RP2D of APG-3288 will be determined during the dose escalation phase based on the incidence of DLTs, overall safety, tolerability, and available pharmacokinetic and pharmacodynamic data.