RecruitingPhase 1NCT06687070

APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors


Sponsor

Ascentage Pharma Group Inc.

Enrollment

50 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called APG-2449 (alone or combined with liposomal doxorubicin chemotherapy) in patients with ovarian cancer that has stopped responding to platinum-based chemotherapy (platinum-resistant), or in patients with certain advanced solid tumors driven by specific gene fusions. **You may be eligible if...** - You have platinum-resistant recurrent ovarian, fallopian tube, or primary peritoneal cancer (for Part B) - You have advanced solid tumors with ALK or ROS1 gene fusions (for Part A, any gender) - You have at least one measurable tumor - You are physically functional (ECOG 0–1) - You are not pregnant or breastfeeding - Your organ function and blood counts are within acceptable ranges **You may NOT be eligible if...** - You had major surgery or trauma in the past 28 days - You received recent anti-cancer treatment - You have previously been treated with a FAK inhibitor drug - You have active brain metastases - You have serious heart or gastrointestinal disease, or uncontrolled fluid around the lungs or abdomen - You had another cancer within the past 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06687070


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