A Study of APG-3288 in Relapsed/Refractory Blood Cancers
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Ascentage Pharma Group Inc.
- Study ID
- NCT07424833
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
- Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation)
- Relapsed/Refractory Follicular Lymphoma (FL)
- Relapsed/Refractory Hematological Malignancies
- Relapsed/Refractory Mantle Cell Lymphoma (MCL)
- Relapsed/Refractory Marginal Zone Lymphoma (MZL)
- Relapsed/Refractory Waldenström Macroglobulinemia (WM)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- APG-3288 — DRUGOrally administered daily; 28 days per cycle.
Study Details
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.
Key Dates
- Start date
- Mar 31, 2026
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1 (Dose Escalation Phase)APG-3288 at multiple dose levels will be evaluated to determine the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD).
- Experimental: Part 2 (Dose Expansion Phase)Indications and dose cohorts to be determined from Part 1
Primary Outcome Measure
Incidence of dose-limiting toxicities (DLTs) at each dose level [ Time Frame: From first dose through the end of Cycle 1 (e.g., Day 1 to Day 28) ]
Central Contacts
- Yifan Zhai, M.D., Ph.D.18998334688
- Qiwei Chen, M.D.
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | - |
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