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APG-2449 in Patients With Advanced Solid Tumors

NCT03917043 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-06-18

No results posted yet for this study

Summary

APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.

Conditions

  • Advanced Solid Cancer
  • Non Small Cell Lung Cancer
  • Esophageal Cancer
  • Ovarian Cancer
  • Malignant Pleural Mesothelioma

Interventions

DRUG

APG-2449

Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle

Sponsors & Collaborators

  • Suzhou Yasheng Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Professor · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • China

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 NCT03917043 on ClinicalTrials.gov