Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID03917043

A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors

Led by Ascentage Pharma Group Inc. · Updated on 2025-06-18

165

Participants Needed

9

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

Ascentage Pharma Group Inc.

Lead Sponsor

S

Suzhou Yasheng Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating APG-2449, a new oral drug that targets multiple enzymes involved in cancer growth, including FAK, ALK, and ROS1. This drug is being studied for its potential to treat patients with advanced solid tumors, such as non-small cell lung cancer, esophageal cancer, ovarian cancer, and malignant pleural mesothelioma. The study aims to find the highest safe dose and recommended dose for further testing while observing how the drug behaves in the body and affects cancer cells. The treatment involves taking APG-2449 capsules daily in 28-day cycles. The study starts with a dose escalation phase using a standard method to gradually increase the dose in small groups of patients until the maximum tolerated dose or recommended phase 2 dose is determined. Up to 30-40 patients may be treated at this dose level to assess safety and drug effects. The drug is given orally and tested as a single agent in this phase 1 trial. Participants will have regular visits to monitor safety, drug levels in the blood, and biological effects on target proteins. Researchers will also measure tumor response using established criteria every four weeks. Eligibility includes having advanced solid tumors with measurable lesions and adequate organ function. The study includes safety assessments and blood tests over 28-day treatment cycles, with the goal of determining the best dose for future studies. The trial is sponsored by Ascentage Pharma Group Inc. and is planned to continue until 2028.

CONDITIONS

Brief Title

APG-2449 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with advanced non-small cell lung cancer positive for ALK/ROS1 gene fusion, malignant pleural mesothelioma, esophageal cancer, or ovarian cancer
  • For expansion stage, patients with specific lung cancer who progressed on or are intolerant to certain targeted therapies and have pFAK expression
  • ECOG Performance Status of 0 or 1
  • Expected life expectancy of at least 3 months
  • At least one measurable lesion by RECIST version 1.1
  • Adequate blood, bone marrow, kidney, liver, and heart function
  • Clinically controlled brain metastases allowed
  • Negative pregnancy test for women of childbearing potential within 7 days before first dose
  • Use of effective contraception during and for 30 days after study drug
  • Ability to understand and sign informed consent
  • Willingness and ability to complete study procedures and follow-up
  • Provide fresh or archived tumor tissue samples within 28 days prior to treatment
Not Eligible

You will not qualify if you...

  • Receiving other anti-cancer therapies or investigational drugs within 28 days before first dose
  • Receiving TKI therapy within 8 days before first dose
  • Unresolved toxicities from prior therapy greater than Grade 1
  • Difficulty swallowing or absorbing oral medication
  • History of significant cardiovascular disease
  • Recent major surgery within 28 days or minor surgery within 14 days before study entry
  • Active symptomatic infections including HIV or hepatitis B/C
  • Known allergies to study drug components
  • Pregnant or breastfeeding women
  • Any condition judged by investigators to risk safety or study assessment
  • Use of certain CYP enzyme inhibitors or inducers within 1 week before first dose
  • Use of CYP3A4 substrates with narrow therapeutic windows within 1 week before first dose

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Multiple 28-day cycles until disease progression or discontinuation

Participants receive oral APG-2449 capsules daily in 28-day cycles to evaluate safety, pharmacokinetics, and pharmacodynamics.

Daily dosing with regular visits during each 28-day cycle

Trial Site Locations

Total: 9 locations

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

2

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Not Yet Recruiting

3

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Not Yet Recruiting

4

Sun-Yat Sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

5

The First affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

6

Henan Provincial Oncology Hospital

Zhengzhou, Henan, China

Actively Recruiting

7

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Actively Recruiting

8

Hunan Provincial Oncology Hospital

Changsha, Hunan, China

Actively Recruiting

9

Zhejiang Provincial Oncology Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

Y

Yifan Zhai, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Safety, pharmacokinetic, pharmacodynamic, and efficacy properties of orally administered APG-2449 in patients with advanced ALK + and ROS1 + non-small-cell lung cancer: a multicentre, open-label, single-arm phase 1 trial.

Yuxiang Ma, Zhengbo Song, Jianhua Chen...

https://pubmed.ncbi.nlm.nih.gov/41146927

Discovery of a novel ALK/ROS1/FAK inhibitor, APG-2449, in preclinical non-small cell lung cancer and ovarian cancer models.

Douglas D Fang, Ran Tao, Guangfeng Wang...

https://pubmed.ncbi.nlm.nih.gov/35820889