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Also known as APG-2449 Capsule
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 in adults with advanced solid tumors, including platinum-resistant recurrent ovarian cancer, non-small cell lung cancer, esophageal cancer, and malignant pleural mesothelioma. It is also being tested as monotherapy or in combination with pegylated liposomal doxorubicin (PLD) in platinum-resistant recurrent ovarian cancer or advanced solid tumors.
APG-2449 targets FAK, ALK, and ROS1, which are tyrosine kinases. By inhibiting these kinases, APG-2449 is designed to interfere with signaling pathways that drive tumor growth and survival. The trials are biomarker-selected, meaning participants are chosen based on specific molecular characteristics of their tumors.
APG-2449 is being developed by Ascentage Pharma Group International, whose American Depositary Shares trade under the ticker AAPG. The company is running the clinical program in China.
APG-2449 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 two recruiting studies evaluating the drug in advanced solid tumors and in platinum-resistant recurrent ovarian cancer.
APG-2449 is being evaluated in two Phase 1 trials, both currently recruiting in China. NCT03917043 is testing APG-2449 in patients with advanced solid tumors, including non-small cell lung cancer, esophageal cancer, ovarian cancer, and malignant pleural mesothelioma, with an enrollment of 165. NCT06687070 is testing APG-2449 as monotherapy or in combination with PLD in platinum-resistant recurrent ovarian cancer or advanced solid tumors, with an enrollment of 90.
Yes, APG-2449 and APG -2449 refer to the same investigational drug. The alternate spelling with a space appears in some sources, but both names denote the same FAK/ALK/ROS1 inhibitor being developed by Ascentage Pharma for advanced solid tumors and platinum-resistant recurrent ovarian cancer.