Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03872206 | Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression | PHASE1 | COMPLETED | 95 | — | — | Apr 16, 2019 | Jan 4, 2023 | Jun 7, 2024 | 16 | United States |
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...