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)
Start Date
3/15/2023
Completion Date
4/1/2028
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Spevatamig (PT886)
Paclitaxel
Gemcitabine
Abraxane
KEYTRUDA® (pembrolizumab)
FOLFOX
CAPOX
FOLFIRINOX
Conditions
Locations
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California 91010
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Sarah Cannon Research Institute (SCRI)
Denver, Colorado 80218
United States
University of Iowa
Iowa City, Iowa 52242
United States
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts 02215
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15232
United States
MD Anderson Cancer Center, GI Medical Oncology Dept
Houston, Texas 77030
United States
NEXT Oncology
Fairfax, Virginia 22031
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States