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An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APG -2449 Monotherapy | Experimental | Part A: Monotherapy for advanced solid tumors. |
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| APG -2449 combined with PLD | Experimental | Part B: Dose exploration and expansion of APG-2449 combined PLD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APG -2449 | Drug | Orally once a day(QD), every 28 days as a cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 28 days |
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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.
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.
Exclusion Criteria:
Part B: Female only.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Zhai, M.D., Ph.D. | Contact | +86-20-28068501 | yzhai@ascentage.com | |
| Wentao Pan, Ph.D. | Contact | Wentao.Pan@ascentage.com |
| Name | Affiliation | Role |
|---|---|---|
| Jundong Li, M.D. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| C041277 | 1-dodecylpyridoxal |
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| PLD | Drug | Injected on the first day of each cycle, every 28 days as a cycle. |
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