NCT05415098

Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas

A Phase I Study of Safety, Pharmacokinetic and Efficacy of Orally Administered APG-5918 in Patients With Advanced Solid Tumors or Hematologic Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1 study that will be conducted in two parts. Part 1 is the dose escalation of APG-5918. Part 2 is the dose expansion of APG-5918. APG-5918 will be administered orally. Patients will be treated in 28-day cycles.

Detailed description

The dose escalation part is to establish the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) when APG-5918 is given orally once daily in subjects with histologically- and/or cytologically-confirmed advanced solid tumors or non-Hodgkin's lymphoma (NHL) that have progressed or are intolerant after treatment with approved therapies or for which there are no standard therapies available. The starting dose of APG-5918 is 50 mg; the doses can be modified depending on toxicity and pharmacokinetic (PK) results based on discussions with the Investigators and Sponsor. If no dose-limiting toxicities (DLTs) or less than two drug related Grade 2 toxicities are observed by the end of Cycle 1, the dose of APG-5918 will be increased in subsequent cohorts. The dose expansion part will be initiated once the MTD or RP2D is established. Approximately 9-12 subjects will be enrolled into two cohorts treating with the appropriate two dose levels at (MTD-1 and MTD) or below MTD (MTD-2 and MTD-1), depending on the comprehensive analysis of the PK, pharmacodynamic (PD), safety and efficacy data of APG-5918. Patients will be randomized 1:1 to each dose cohort.

Conditions

• Nasopharyngeal Carcinoma
• Castrate Resistant Prostate Cancer
• Gastric Cancer
• Ovarian Clear Cell Carcinoma
• Mesothelioma
• Sarcoma
• Non Hodgkin Lymphoma
• B Cell Lymphoma
• Epithelioid Sarcoma

Interventions

Type	Name	Description
DRUG	APG-5918	The investigational drug product is formulated as oral tablets of 50 mg or 200 mg that contain APG-5918 as the active ingredient. APG-5918 will be orally administered once every day on 28-day cycles. The dosage of APG-5918 depends on the dose level to which the patient is assigned. Each dose of APG-5918 will be taken orally in fasted condition in the study.

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2022-06-10
• Last updated: 2022-11-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study