Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as APG-1252 for injection, Pelcitoclax
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 in oncology for EGFR-positive non-small cell lung cancer and small cell lung cancer. It is being evaluated in Phase 1 clinical trials, both as a single agent in small cell lung cancer and other solid tumors, and in combination with osimertinib in EGFR TKI-resistant non-small cell lung cancer.
APG-1252 targets Bcl-2 and Bcl-xL, two proteins in the Bcl-2 family that regulate apoptosis, or programmed cell death. By inhibiting these proteins, APG-1252 is designed to promote cell death in tumor cells that depend on them for survival.
APG-1252 is being developed by Ascentage Pharma Group International, whose American Depositary Shares trade on the Nasdaq under the ticker AAPG. The company is advancing the compound in clinical trials for lung cancer indications.
APG-1252 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 program includes studies in EGFR-positive non-small cell lung cancer and small cell lung cancer.
APG-1252 has been studied in two Phase 1 trials. NCT04001777 is evaluating APG-1252 plus osimertinib in EGFR TKI-resistant non-small cell lung cancer and is active but not recruiting. NCT03080311 studied APG-1252 in small cell lung cancer and other solid tumors and is completed.
Yes, APG-1252 trials are biomarker-selected. The Phase 1 study NCT04001777 enrolls patients with EGFR-positive non-small cell lung cancer, meaning participants are chosen based on the presence of specific EGFR mutations. This approach targets a molecularly defined patient population.