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Also known as APG-1387 for Injection
APG-1387 · 2 trials · 2 indications
Patients with APG-1387 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.0.3
| Arm | Type | Description |
|---|---|---|
| APG-1387 for Injection | EXPERIMENTAL | APG-1387 will be explored sequentially using a escalation scheme at the dose escalation phase. |
| Name | Type | Description |
|---|---|---|
| APG-1387 for Injection | DRUG | Multiple dose cohorts, 30 minute IV infusion, once weekly for 4 weeks . |
Inclusion Criteria 1. Age ≥18 and ≤ 65 years old. 2. Confirmed diagnosis of chronic hepatitis B, HBsAg positive≥6 months. 3. HBV DNA≥2×103 IU/mL for HBeAg negative patients, HBV DNA≥1×104IU/mL for HBeAg positive patients in screening phase. 4. ALT≥ ULN and \<10 ×ULN in screening phase (exclude non-...
APG-1387 is an investigational small molecule developed by Ascentage Pharma Group International (ticker AAPG). It has been studied in Phase 1 clinical trials for advanced solid tumors or hematologic malignancies and for chronic hepatitis B. It is not approved and remains in clinical development.
APG-1387 has been evaluated in Phase 1 trials for two indications: advanced solid tumors or hematologic malignancies, and chronic hepatitis B. Both studies are completed. The drug is investigational and has not been approved for any indication.
APG-1387 is developed by Ascentage Pharma Group International, which trades under the ticker AAPG as American Depositary Shares. The company sponsored the Phase 1 clinical trials of the drug in the United States and China.
APG-1387 is in Phase 1. Two Phase 1 trials have been completed: one in advanced solid tumors or hematologic malignancies and one in chronic hepatitis B. There are currently no active trials, and the drug is not FDA approved.
APG-1387 has been studied in two completed Phase 1 trials. NCT03386526 evaluated the drug in patients with advanced solid tumors or hematologic malignancies in the United States, enrolling 90 patients. NCT03585322 evaluated it in patients with chronic hepatitis B in China, enrolling 49 patients.
Yes, APG-1387 for Injection is another name for APG-1387. Both refer to the same investigational small molecule developed by Ascentage Pharma Group International (ticker AAPG) for advanced solid tumors or hematologic malignancies and chronic hepatitis B.