Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APG-1252 · 2 trials · 3 indications
To determine the maximum tolerated dose (MTD) of APG-1252 in subjects with NSCLC
Recommended Phase 2 dose (RP2D) of APG-1252 in subjects with NSCLC
Number of participants with APG-1252 treatment-related adverse events as assessed by NCI CTCAE v4.03
If ≥ 2/6 patients develop a DLT at any dose level, then this dose will be declared as the MTD
| Arm | Type | Description |
|---|---|---|
| APG-1252 plus Osimertinib (AZD9291) | EXPERIMENTAL | APG-1252 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase; Dose of osimertinib will be fixed at 80mg QD based on approved label. |
| APG-1252 | EXPERIMENTAL | An accelerated dose escalation scheme will be utilized initially with one patient enrolled per cohort. If at 10 mg or 20 mg dose level, any occurrence in cycle 1 of one ≥ Grade 2 adverse event related or possibly related to APG-1252 (graded as per the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0) is the trigger for converting to a standard 3+3 design at that dose level. |
| Name | Type | Description |
|---|---|---|
| APG-1252 | DRUG | Multiple dose cohorts, 30 minute IV infusion, weekly for 3 weeks of a cycle with 21days. |
| Osimertinib Mesylate Tablets | DRUG | Osimertinib Mesylate Tablets 40mg/80 mg, one time a day until disease progression |
Inclusion Criteria: Only applicable to the dose-finding stage: Patients with NSCLC with disease progression after first-line EGFR TKI and platinum-based chemotherapy. Only applicable to dose-expansion stage: Cohort 1: Patients with NSCLC with disease progression after third-generation EGFR TKI a...
APG-1252 is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer and EGFR Positive Non-small Cell Lung Cancer. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
APG-1252 targets Bcl-2 and Bcl-xL, which are proteins involved in regulating cell survival. By inhibiting these proteins, the drug is designed to promote apoptosis, or programmed cell death, in cancer cells.
APG-1252 is being developed by Ascentage Pharma Group International, whose American Depository Shares trade under the ticker AAPG. The company is conducting clinical trials for this drug in oncology indications.
APG-1252 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still being evaluated for safety and efficacy in clinical trials.
APG-1252 has been studied in two Phase 1 trials. NCT03080311, completed in the United States, enrolled 50 patients with Small Cell Lung Cancer or other solid tumors. NCT04001777, active but not recruiting in China, is studying APG-1252 plus osimertinib in EGFR TKI resistant NSCLC patients with a target enrollment of 80.
APG-1252 is a distinct investigational compound developed by Ascentage Pharma. It is not known to have alternative names or to be the same as any other approved drug. Its unique mechanism targets Bcl-2 and Bcl-xL proteins.