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

NCT05415098 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-11-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Yifan Zhai, MD, PhD · Ascentage Pharma Group Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415098 on ClinicalTrials.gov