RecruitingPhase 1

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

China90 participantsStarted 2024-12-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. AE caused by previous treatment must recover to ≤ grade 1.
. Sufficient bone marrow, liver, kidney and coagulation function.
. Female patients must be in a non-pregnant and non-lactating state.
. Able to understand and willing to sign informed consent.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment-related adverse events per NCI-CTCAE version 5.0.

Timeframe: Up to 1 year

Dose Limiting Toxicity(DLT).

Timeframe: Up to 28 days

Trial details

NCT IDNCT06687070

SponsorAscentage Pharma Group Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Yifan Zhai, M.D., Ph.D.

+86-20-28068501 yzhai@ascentage.com

View on ClinicalTrials.gov More Platinum-resistant Recurrent Ovarian Cancer trials