Platinum-resistant Recurrent Ovarian Cancer, Advanced Solid Tumor
Conditions
Keywords
APG-2449
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.
Interventions
DRUGAPG -2449
Orally once a day(QD), every 28 days as a cycle.
DRUGPLD
Injected on the first day of each cycle, every 28 days as a cycle.
Sponsors
Ascentage Pharma Group Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYifan Zhai, M.D., Ph.D.
Backup ContactWentao Pan, Ph.D.
Outcome results
None listed