APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.

About this trial

This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.

Eligibility criteria

Qualifiers

Age ≥18 years old.

Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia

Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition,

Life expectancy ≥ 3 months.

Disqualifiers

Prior history of allogeneic cell transplant.

Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.

Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.

Received biologic (< 28 days), small molecule targeted therapies (< 5 half-life) or other anti-cancer therapy within 21 days of study entry.

Trial design

Treatments tested in this trial

  • APG-2575

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators