drugset / Trial / NCT05482893
Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including 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), pancreatic ductal adenocarcinoma (PDAC) and colorectal carcinoma (CRC).
Timeline
- Start
- 2023-03-15
- Primary completion
- 2027-12
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abraxane | Small molecule | — | — |
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Spevatamig | Monoclonal antibody | — | — |
| Subject | TAS-102 | Small molecule | — | — |