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

Last updated: February 24, 2025
Sponsor: Ascentage Pharma Group Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Ovarian Cysts

Treatment

PLD

APG -2449

Clinical Study ID

NCT06687070
APG2449OC101
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Part A: No gender limitation. Patients with histologically and/or cytologicallyconfirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and variousadvanced tumors. Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, orprimary 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 totreatment.

Exclusion

Exclusion Criteria:

  1. Undergone major surgery or major trauma within 28 days before first dose or adiagnostic 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 histologicaltypes 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 beforefirst 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 orP-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates andthe 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 fromentering the study.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: PLD
Phase: 1
Study Start date:
December 17, 2024
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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