Actively Recruiting
APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
Led by Ascentage Pharma Group Inc. · Updated on 2025-02-26
50
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
CONDITIONS
Official Title
APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part A: Patients of any gender with ALK/ROS1 gene fusion positive non-small cell lung cancer or various advanced tumors.
- Part B: Female patients with ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.
- At least one measurable tumor lesion.
- ECOG performance score of 0 or 1.
- Life expectancy of 3 months or more.
- Adverse events from previous treatments recovered to grade 1 or less.
- Adequate bone marrow, liver, kidney, and coagulation function.
- Female patients must not be pregnant or breastfeeding.
- Ability to understand and sign informed consent.
- Willingness to provide fresh or archived tumor tissue samples before treatment.
You will not qualify if you...
- Major surgery or trauma within 28 days before first dose or diagnostic biopsy within 14 days before first dose.
- Received systemic antitumor treatments, including investigational drugs, recently.
- Radiotherapy within 14 days before first dose.
- Previous treatment with FAK inhibitors.
- Tumors outside ovarian cancer or other histological types within 3 years before first dose.
- Active central nervous system metastases or cancerous meningitis.
- Major cardiovascular or cerebrovascular disease within 6 months before first dose.
- Pleural effusion, pericardial effusion, or ascites requiring drainage within 1 month before first dose.
- Malabsorption syndrome or inability to take oral medications.
- Severe gastrointestinal disease.
- Serious or uncontrolled systemic disease or active chronic infections.
- Allergy to APG-2449, PLD, or their components.
- Previous cumulative anthracycline dose exceeding 550 mg/m2.
- Use of certain CYP3A4, CYP2C9, CYP2C19, or P-gp inhibitors or inducers within a week before first dose.
- Other conditions deemed by investigators to prevent study participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
W
Wentao Pan, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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