APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
- Conditions
- Platinum-resistant Recurrent Ovarian CancerAdvanced Solid Tumor
- Interventions
- Drug: APG -2449Drug: PLD
- Registration Number
- NCT06687070
- Lead Sponsor
- Ascentage Pharma Group Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
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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.
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At least one measurable tumor lesion.
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ECOG score is 0~1.
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Life expectancy of ≥3 months.
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AE caused by previous treatment must recover to ≤ grade 1.
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Sufficient bone marrow, liver, kidney and coagulation function.
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Female patients must be in a non-pregnant and non-lactating state.
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Able to understand and willing to sign informed consent.
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Patients are required to provide fresh or archived tumor tissue samples prior to treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description APG -2449 Monotherapy APG -2449 Part A: Monotherapy for advanced solid tumors. APG -2449 combined with PLD APG -2449 Part B: Dose exploration and expansion of APG-2449 combined PLD. APG -2449 combined with PLD PLD Part B: Dose exploration and expansion of APG-2449 combined PLD.
- Primary Outcome Measures
Name Time Method Treatment-related adverse events per NCI-CTCAE version 5.0. Up to 1 year The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Dose Limiting Toxicity(DLT). 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China