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New treatment option for Platinum-resistant Recurrent Ovarian Cancer
Official title APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
ClinicalTrials.gov ID: NCT06687070
What this study is testing
What is APG -2449?
APG -2449 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for platinum-resistant recurrent ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer...
- 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.
You likely can't join if
- 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.
- Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
- Known active central nervous system (CNS) metastases and/or cancerous meningitis.
See the full eligibility 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. Part B: Female only. Histologically proven...
- 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.
- Patients are required to provide fresh or archived tumor tissue samples prior to treatment.
- 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.
- Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
- Known active central nervous system (CNS) metastases and/or cancerous meningitis.
- Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.
- Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.
- Malabsorption syndrome, or inability to take medications orally.
- Severe gastrointestinal disease.
- Any serious or uncontrolled systemic disease; Various chronic active infections.
- Allergy to APG-2449 or PLD and its drug components.
- Previous cumulative doses of anthracyclines ≥550 mg/m\^2.
- 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...
- Other factors that, in the investigator's judgment, should prevent the patient from entering the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.