Evaluating APG-2449 for treating advanced ovarian cancer and solid tumors

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

This study is testing a new drug called APG-2449 to see if it can safely help people with advanced ovarian cancer and other solid tumors, both on its own and when combined with another treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06687070 on ClinicalTrials.gov

What this trial studies

This Phase I trial is designed to assess the safety, tolerability, and efficacy of APG-2449, both as a standalone treatment and in combination with PLD, for patients with platinum-resistant recurrent ovarian cancer and advanced solid tumors. The trial consists of two parts: Part A focuses on the monotherapy of APG-2449, while Part B examines its combination with PLD specifically for ovarian cancer. Participants will be monitored for adverse effects and treatment responses to determine the optimal dosing and effectiveness of the drug.

Who should consider this trial

Good fit: Ideal candidates include women with histologically confirmed ovarian cancer or advanced solid tumors who meet specific health criteria.

Not a fit: Patients who have recently undergone major surgery or those with certain pre-existing conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment choices for advanced ovarian cancer and solid tumors.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in targeting advanced cancers with new therapies.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jundong Li, M.D. — Sun Yat-sen University
• Study coordinator: Yifan Zhai, M.D., Ph.D.

Conditions Platinum-resistant Recurrent Ovarian Cancer; Advanced Solid Tumor; APG-2449