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Also known as GB226, genolimzumab
APL-501 · 1 trial · 4 indications
Adverse events, serious adverse events, dose limiting toxicities according to the National Cancer Institute (NCI) Terminology Criteria for Adverse Events (CTCAE v4.03)
| Arm | Type | Description |
|---|---|---|
| Single-Arm | EXPERIMENTAL | APL-501 |
| Name | Type | Description |
|---|---|---|
| APL-501 | DRUG | Subjects will be assigned to a dose level in the order of study entry. Treatment includes a minimum of four 28-day cycles at three planned dose levels (1, 3, and 10 mg/kg). In the Dose Escalation Segment, each treatment cycle is comprised of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In the Cohort Extension, the treatment cycle will consist of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In Dose and Disease Expansion, the treatment cycle will consist of 2 doses of study drug (non-weight based dosing of 400 mg) administered on Days 1 and 15 of a 28-day cycle. |
Major Inclusion Criteria: • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent. Dose Escalation: * Histologically and / or cytological confirmed solid tumors: colorectal, endometrial, gastric including, gastroesophageal junctio...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
APL-501 is an investigational small molecule developed by Apollomics Inc. (ticker APLM) for the treatment of advanced or relapsed and recurrent solid tumors. It is a PDCD1 inhibitor and has been studied in a Phase 1 clinical trial in Australia. It is not an approved therapy and remains in clinical development.
APL-501 is being studied for select advanced or relapsed and recurrent solid tumors, including microsatellite instability, mismatch repair deficiency, and cancer of unknown primary site. The Phase 1 trial enrolled 30 patients aged 18 years and older in Australia. It is investigational and has not been approved for any indication.
APL-501 targets PDCD1, also known as PD-1. It is classified as an inhibitor of this target, a checkpoint receptor involved in regulating immune responses. By inhibiting PDCD1, the small molecule is designed to act in oncology settings, and it has been evaluated in a biomarker-selected patient population.
APL-501 is being developed by Apollomics Inc., which trades under the ticker APLM. The company sponsored the Phase 1 study of APL-501 in patients with select advanced or relapsed and recurrent solid tumors. Apollomics is the developer associated with this asset.
APL-501 is in Phase 1 clinical development. Its single trial, NCT03053466, has been completed and enrolled 30 patients. The study was an uncontrolled, non-randomized, open-label Phase 1 trial, so APL-501 is investigational and has not been approved by the FDA or any other regulator.
APL-501 has been studied in one clinical trial, NCT03053466, titled APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors. The Phase 1 trial was completed, enrolled 30 patients, and was conducted in Australia. It included patients with solid tumors, microsatellite instability, mismatch repair deficiency, and cancer of unknown primary site.