Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HPN536 Fixed 6 to 560 ng/kg · 1 trial · 1 indication
Assess safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with of patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, pancreatic adenocarcinoma, or mesothelioma (pleural and primary peritoneal) by adverse events (CTCAE v5.0)
Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)
Evaluate overall response rate (ORR) as assessed by RECIST
| Arm | Type | Description |
|---|---|---|
| Fixed IV | EXPERIMENTAL | HPN536 administered once weekly via IV infusion in doses ranging from 6 to 560 ng/kg |
| 1 Prime Step IV 600-1200 ng/kg Target | EXPERIMENTAL | Step-dosing IV cohorts who received a single Prime Dose followed by the Target Dose (200/600 ng/kg, 200/1200 ng/kg, and 500/900 ng/kg) |
| 2 Prime Step IV 900-14000 ng/kg Target | EXPERIMENTAL | Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (200/600/900 ng/kg and 200/600/1200 ng/kg; 500/900/1200 ng/kg, 500/900/1800 ng/kg, 500/900/3600 ng/kg, 500/900/7200 ng/kg, and 500/900/14400 ng/kg) |
| Name | Type | Description |
|---|---|---|
| HPN536 Fixed IV 6 to 560 ng/kg | BIOLOGICAL | Fixed dose IV cohorts at doses from 6 to 560 ng/kg |
| HPN536 1 Prime Step IV 600-1200 ng/kg Target | BIOLOGICAL | Step-dosing IV cohorts who received a single Prime Dose followed by the Target Dose (200/600 ng/kg, 200/1200 ng/kg, and 500/900 ng/kg) |
| 2 Prime Step IV 900-14000 ng/kg Target | BIOLOGICAL | Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (200/600/900 ng/kg and 200/600/1200 ng/kg; 500/900/1200 ng/kg, 500/900/1800 ng/kg, 500/900/3600 ng/kg, 500/900/7200 ng/kg, and 500/900/14400 ng/kg) |
1. One of the following progressive advanced or metastatic cancers: 1. Epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum refractory or platinum resistant 2. Pancreatic adenocarcinoma that is locally advanced, and now with progressive disease on or after front-l...
HPN536 Fixed 6 to 560 ng/kg is an investigational monoclonal antibody being studied for the treatment of advanced cancers associated with mesothelin expression. It is intended for patients with cancers that express mesothelin, a protein found on the surface of certain tumor cells.
HPN536 Fixed 6 to 560 ng/kg targets mesothelin, a protein expressed on the surface of certain cancer cells. By binding to mesothelin, the antibody is designed to direct an immune response against tumor cells that express this protein, potentially leading to their destruction.
HPN536 Fixed 6 to 560 ng/kg is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is an investigational monoclonal antibody in clinical development.
HPN536 Fixed 6 to 560 ng/kg is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
HPN536 Fixed 6 to 560 ng/kg has been studied in a Phase 1 clinical trial with the identifier NCT03872206. This trial, titled "Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression," enrolled 95 participants in the United States and has been completed.
HPN536 Fixed 6 to 560 ng/kg is a specific dose formulation of the investigational drug HPN536. The name refers to the fixed dose range of 6 to 560 nanograms per kilogram, while HPN536 is the general drug name used in clinical trial documentation.