Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as APG -2449
APG-2449 · 2 trials · 7 indications
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
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.
To determine the maximum tolerated dose (MTD) of APG-2449 in subjects with advanced solid tumors
To determine the tentative recommended Phase 2 dose (RP2D) of APG-2449 in subjects with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| APG -2449 Monotherapy | EXPERIMENTAL | Part A: Monotherapy for advanced solid tumors. |
| APG -2449 combined with PLD | EXPERIMENTAL | Part B: Dose exploration and expansion of APG-2449 combined PLD. |
| APG-2449 | EXPERIMENTAL | APG-2449 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase and up to 30-40 patient at the MTD/RP2D dose level. |
| Name | Type | Description |
|---|---|---|
| APG -2449 | DRUG | Orally once a day(QD), every 28 days as a cycle. |
| PLD | DRUG | Injected on the first day of each cycle, every 28 days as a cycle. |
| APG-2449 | DRUG | Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle |
Inclusion Criteria: 1. 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 perito...
APG-2449 is an investigational small molecule being studied for the treatment of platinum-resistant recurrent ovarian cancer and advanced solid cancers. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
APG-2449 targets FAK, ALK, and ROS1, which are tyrosine kinases. By inhibiting these targets, the drug aims to interfere with cancer cell signaling pathways involved in tumor growth and progression.
APG-2449 is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG. The company is conducting clinical trials for this investigational oncology drug.
APG-2449 is in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. Clinical trials are currently recruiting participants to evaluate its safety and efficacy.
APG-2449 is being studied in two Phase 1 trials. NCT03917043 evaluates the drug in patients with advanced solid tumors, including non-small cell lung cancer and ovarian cancer. NCT06687070 studies APG-2449 alone or with PLD in platinum-resistant recurrent ovarian cancer and advanced solid tumors.