APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

February 24, 2025 updated by: Ascentage Pharma Group Inc.

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors

An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.

Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Jundong Li, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

    Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.

  2. At least one measurable tumor lesion.
  3. ECOG score is 0~1.
  4. Life expectancy of ≥3 months.
  5. AE caused by previous treatment must recover to ≤ grade 1.
  6. Sufficient bone marrow, liver, kidney and coagulation function.
  7. Female patients must be in a non-pregnant and non-lactating state.
  8. Able to understand and willing to sign informed consent.
  9. Patients are required to provide fresh or archived tumor tissue samples prior to treatment.

Exclusion Criteria:

  1. Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.
  2. Received systemic antitumor drugs, including investigational drugs.
  3. Received radiotherapy within 14 days before first dose.
  4. Previous treatment with FAK inhibitors.
  5. Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
  6. Known active central nervous system (CNS) metastases and/or cancerous meningitis.
  7. Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.
  8. Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.
  9. Malabsorption syndrome, or inability to take medications orally.
  10. Severe gastrointestinal disease.
  11. Any serious or uncontrolled systemic disease; Various chronic active infections.
  12. Allergy to APG-2449 or PLD and its drug components.
  13. Previous cumulative doses of anthracyclines ≥550 mg/m^2.
  14. Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor/inducer or P-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates and the drugs of a narrow treatment window within a week before first dose.
  15. Other factors that, in the investigator's judgment, should prevent the patient from entering the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APG -2449 Monotherapy
Part A: Monotherapy for advanced solid tumors.
Drug: APG -2449
Orally once a day(QD), every 28 days as a cycle.
Experimental: APG -2449 combined with PLD
Part B: Dose exploration and expansion of APG-2449 combined PLD.
Drug: APG -2449
Orally once a day(QD), every 28 days as a cycle.
Drug: PLD
Injected on the first day of each cycle, every 28 days as a cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events per NCI-CTCAE version 5.0.
Time Frame: Up to 1 year
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Up to 1 year
Dose Limiting Toxicity(DLT).
Time Frame: Up to 28 days
DLT will be defined based on the rate of drug-related grade 3 to 5 adverse events experienced within the first 4 weeks of study treatment. These will be assessed per NCI-CTCAE version 5.0.
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascentage Pharma Group Inc.

Investigators

  • Principal Investigator: Jundong Li, M.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APG2449OC101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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