NCT06687070 APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
| NCT ID | NCT06687070 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ascentage Pharma Group Inc. |
| Condition | Platinum-resistant Recurrent Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2024-12-17 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jundong Li, M.D.
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06687070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Platinum-resistant Recurrent Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06687070 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06687070 currently recruiting?
Yes, NCT06687070 is actively recruiting participants. Contact the research team at yzhai@ascentage.com for enrollment information.
Where is the NCT06687070 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06687070 clinical trial?
NCT06687070 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Jundong Li, M.D. at Sun Yat-Sen University Cancer Center. The trial plans to enroll 90 participants.
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