APG-2575

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

What will happen during the trial?

APG-2575 will be administered orally, once daily for consecutive 4 weeks as one cycles. Initially, the start dose is 20mg. Single patient cohorts will be evaluated, the dose of APG-2575 will be increased in subsequent cohorts, to 50 mg, 100 mg, 200 mg, 400 mg, 600mg and 800mg accordingly. If there is any one of the following event is observed, a DLT, two drug related Grade 2 toxicities or one drug related ≥ Grade 3 toxicity, or laboratory or clinical TLS, or suspected hypersensitivity reaction occur in Cycle 1, or dose level of 400 mg is reached, the dose escalation will convert to the standard 3+3 design, If ≥ 2/6 patients develop DLT at any dose level dose escalation will cease and the dose level immediately below will be expanded to 6 patients. If ≤ 1/6 patients develop a DLT at the highest dose reached this will be declared the MTD. After the MTD is defined, a maximum of 20 patients will be treated at that dose level.

More Information

Trial Status
Accepting patients
Trial Phase
Phase 1
Enrollment
90 patients (estimated)
Sponsors
Ascentage Pharma Group Inc.
Tags
BCL-2 Inhibitor
Trial Type
Treatment
Last Update
2 weeks ago
SparkCures ID
1070
NCT Identifier
NCT03537482

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