drugset / Trial / NCT05482893
Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).
Timeline
- Start
- 2023-03-15
- Primary completion
- 2027-12
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spevatamig | Monoclonal antibody | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |