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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C1
Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2
Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2
Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D.
Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only)
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886)
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGSarah Cannon Research Institute (SCRI)
Denver, Colorado, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGDana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGDuke Cancer Center
Durham, North Carolina, United States
RECRUITINGUniversity of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
RECRUITINGMD Anderson Cancer Center, GI Medical Oncology Dept
Houston, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITING...and 1 more locations
To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy.
Time frame: Through study completion, an average of 2 years
To evaluate anti-tumor activity of PT886 as assessed by ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.
Time frame: Through study completion.
To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy.
Time frame: Through study completion.
To evaluate the pharmacokinetics of Spevatamig (PT886).
Time frame: Through study completion, an average of 2 years
To evaluate the immunogenicity (ADA) of Spevatamig (PT886).
Time frame: Through study completion, an average of 2 years
To evaluate anti-tumor activity as assessed by additional measures other than ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.
Time frame: Through study completion, an average of 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.