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

NCT06687070 | Recruiting Phase 1

• 1 other identifier: APG2449OC101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platinum-resistant Recurrent Ovarian Cancer; Advanced Solid Tumor

Keywords

APG-2449

Outcome Measures

Primary Outcomes (2)

• Treatment-related adverse events per NCI-CTCAE version 5.0.

  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).

  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

Study Arms (2)

APG -2449 Monotherapy

EXPERIMENTAL

Part A: Monotherapy for advanced solid tumors.

Drug: APG -2449

APG -2449 combined with PLD

EXPERIMENTAL

Part B: Dose exploration and expansion of APG-2449 combined PLD.

Drug: APG -2449; Drug: PLD

Interventions

APG -2449 DRUG

Orally once a day(QD), every 28 days as a cycle.

APG -2449 Monotherapy; APG -2449 combined with PLD

PLD DRUG

Injected on the first day of each cycle, every 28 days as a cycle.

APG -2449 combined with PLD

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Part B: Female only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

1-dodecylpyridoxal

Study Officials

• Jundong Li, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86-20-28068501; yzhai@ascentage.com

Wentao Pan, Ph.D.

CONTACT

Wentao.Pan@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: December 17, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

CN (1)