Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for advanced solid tumors or hematologic malignancies and for chronic hepatitis B. It is in Phase 1 clinical development and is not yet approved by the FDA.
APG-1387 is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG. The company is conducting clinical trials for this investigational drug in oncology and infectious disease indications.
APG-1387 is in Phase 1 clinical development. It has completed Phase 1 trials in advanced solid tumors or hematologic malignancies and in chronic hepatitis B, but it remains investigational and is not FDA approved.
APG-1387 has completed two Phase 1 trials: NCT03386526 in patients with advanced solid tumors or hematologic malignancies in the United States, and NCT03585322 in patients with chronic hepatitis B in China. Both trials are completed.
No alternative names for APG-1387 have been disclosed. It is referred to solely by its code name APG-1387 in clinical trial registrations and company communications.