APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
At least one measurable tumor lesion.
ECOG score is 0~1.
Life expectancy of ≥3 months.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
APG -2449
DrugOrally once a day(QD), every 28 days as a cycle.
PLD
DrugInjected on the first day of each cycle, every 28 days as a cycle.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: APG -2449 MonotherapyExperimental treatment 1 intervention
Group B: APG -2449 combined with PLDExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Treatment-related adverse events per NCI-CTCAE version 5.0.
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Time frame
Up to 1 year2
Dose Limiting Toxicity(DLT).
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.
Time frame
Up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov