NCT06687070RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 12 Nov 2024
- Start date
- 17 Dec 2024
- Primary completion date
- May 2027
- Lead sponsor
- Ascentage Pharma Group Inc.
- Diseases
- Ovarian cancer
- NCT number
- NCT06687070
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 17 Dec 2024 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
- 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.
- 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 week before first dose.
Other illness
- Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years 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.
Other
- Known active central nervous system (CNS) metastases and/or cancerous meningitis.
- Other factors that, in the investigator's judgment, should prevent the patient from entering the study.
Who the study is looking for
- 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 ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.