APG -2449: Orally once a day(QD), every 28 days as a cycle.
PLD: Injected on the first day of each cycle, every 28 days as a cycle.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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