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)

NCT05482893

Phase 1/2 Recruiting 258 enrolled Phanes Therapeutics Merck Sharp & Dohme LLC · collab
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

EvaluationDrugModalityDoseRoute
Subject Spevatamig Monoclonal antibody
Background Gemcitabine Small molecule
Background Paclitaxel Small molecule
Background Pembrolizumab Monoclonal antibody