Platinum-resistant Recurrent Ovarian CancerPhase 1NCT06687070
APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
A Phase 1 study testing APG -2449 and PLD in people with Platinum-resistant Recurrent Ovarian Cancer and Advanced Solid Tumor, run by Ascentage Pharma Group Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platinum-resistant Recurrent Ovarian Cancer, Advanced Solid Tumor
- What is being tested?
- APG -2449 and PLD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 week before first dose.
- Other factors that, in the investigator's judgment, should prevent the patient from entering the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wentao Pan, Ph.D. contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jundong Li, M.D., 020-87343292, lijd@sysucc.org.cn
Jundong Li, M.D.
About this study
Official title: 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
An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
Read the detailed description
Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.
Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.
- Being tested
- APG -2449, PLD
- Keywords
- APG-2449
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG -2449Drug
Orally once a day(QD), every 28 days as a cycle.
PLDDrug
Injected on the first day of each cycle, every 28 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| APG -2449 Monotherapy | Experimental | Part A: Monotherapy for advanced solid tumors. Receives: Drug: APG -2449 |
| APG -2449 combined with PLD | Experimental | Part B: Dose exploration and expansion of APG-2449 combined PLD. Receives: Drug: APG -2449; Drug: PLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events per NCI-CTCAE version 5.0.
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Measured: Up to 1 year
Dose Limiting Toxicity(DLT).
DLT will be defined based on the rate of drug-related grade 3 to 5 adverse events experienced within the first 4 weeks of study treatment. These will be assessed per NCI-CTCAE version 5.0.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start17 Dec 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jundong Li, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687070
- Sponsor's protocol ID
- APG2449OC101
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06687070
- Acronym / sponsor ID
- APG2449OC101
- Keywords
- APG-2449
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
Detailed description
Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.
Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APG -2449 Monotherapy | Experimental | Drug: APG -2449Part A: Monotherapy for advanced solid tumors. |
| APG -2449 combined with PLD | Experimental | Drug: APG -2449, Drug: PLDPart B: Dose exploration and expansion of APG-2449 combined PLD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG -2449Orally once a day(QD), every 28 days as a cycle. | Drug | APG -2449 Monotherapy, APG -2449 combined with PLD |
| PLDInjected on the first day of each cycle, every 28 days as a cycle. | Drug | APG -2449 combined with PLD |
Primary outcome
Treatment-related adverse events per NCI-CTCAE version 5.0.
Time frame: Up to 1 year
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Dose Limiting Toxicity(DLT).
Time frame: Up to 28 days
DLT will be defined based on the rate of drug-related grade 3 to 5 adverse events experienced within the first 4 weeks of study treatment. These will be assessed per NCI-CTCAE version 5.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wentao Pan, Ph.D. contact
Jundong Li, M.D. principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APG -2449 and PLD in people with Platinum-resistant Recurrent Ovarian Cancer and Advanced Solid Tumor, run by Ascentage Pharma Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Zhai, M.D., Ph.D. (+86-20-28068501, yzhai@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events per NCI-CTCAE version 5.0. (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.