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

APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST (NCT06687070) is a Phase 1 interventional studying Platinum-resistant Recurrent Ovarian Cancer and Advanced Solid Tumor, sponsored by Ascentage Pharma Group Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Platinum-resistant Recurrent Ovarian Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Platinum-resistant Recurrent Ovarian Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 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. 2. At least one measurable tumor lesion. 3. ECOG score is 0\~1. 4. Life expectancy of ≥3 months. 5. AE caused by previous treatment must recover to ≤ grade 1. 6. Sufficient bone marrow, liver, kidney and coagulation function. 7. Female patients must be in a non-pregnant and non-lactating state. 8. Able to understand and willing to sign willing to sign a consent form. 9. Patients are required to provide fresh or archived tumor tissue samples prior to treatment. Who Should NOT Join This Trial: 1. Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose. 2. Received systemic antitumor drugs, including investigational drugs. 3. Received radiotherapy within 14 days before first dose. 4. Previous treatment with FAK inhibitors. 5. Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose. 6. Known active central nervous system (CNS) metastases and/or cancerous meningitis. 7. Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose. 8. Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose. 9. Malabsorption syndrome, or inability to take medications orally. 10. Severe gastrointestinal disease. 11. Any serious or uncontrolled systemic disease; Various chronic active infections. 12. Allergy to APG-2449 or PLD and its drug components. 13. Previous cumulative doses of anthracyclines ≥550 mg/m\^2. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. 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. 2. At least one measurable tumor lesion. 3. ECOG score is 0\~1. 4. Life expectancy of ≥3 months. 5. AE caused by previous treatment must recover to ≤ grade 1. 6. Sufficient bone marrow, liver, kidney and coagulation function. 7. Female patients must be in a non-pregnant and non-lactating state. 8. Able to understand and willing to sign informed consent. 9. Patients are required to provide fresh or archived tumor tissue samples prior to treatment. Exclusion Criteria: 1. Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose. 2. Received systemic antitumor drugs, including investigational drugs. 3. Received radiotherapy within 14 days before first dose. 4. Previous treatment with FAK inhibitors. 5. Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose. 6. Known active central nervous system (CNS) metastases and/or cancerous meningitis. 7. Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose. 8. Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose. 9. Malabsorption syndrome, or inability to take medications orally. 10. Severe gastrointestinal disease. 11. Any serious or uncontrolled systemic disease; Various chronic active infections. 12. Allergy to APG-2449 or PLD and its drug components. 13. Previous cumulative doses of anthracyclines ≥550 mg/m\^2. 14. 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. 15. Other factors that, in the investigator's judgment, should prevent the patient from entering the study.

Treatments Being Tested

DRUG

APG -2449

Orally once a day(QD), every 28 days as a cycle.

DRUG

PLD

Injected on the first day of each cycle, every 28 days as a cycle.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06687070), the sponsor (Ascentage Pharma Group Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06687070 clinical trial studying?

An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06687070?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06687070?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06687070. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06687070. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.