This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig (PT217) as a monotherapy and in combination with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
203
A bispecific antibody (bsAb) against DLL3 and CD47.
Administered per Standard of Care.
Administered per Standard of Care.
Administered per Standard of Care.
Administered per Standard of Care.
Administered per Standard of Care.
Administered per Standard of Care.
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 at HealthONE
Denver, Colorado, United States
RECRUITINGYale University Cancer Center
New Haven, Connecticut, United States
RECRUITINGSidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGWashington University School of Medicine (Siteman Cancer Center)
St Louis, Missouri, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITING...and 5 more locations
To determine recommended dose for expansion (RDE) of Peluntamig (PT217).
Time frame: Through study completion, up to approximately 3 years.
To evaluate the safety and tolerability of Peluntamig (PT217).
Time frame: Through study completion, up to approximately 3 years.
To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments as assessed by ORR.
Time frame: Through study completion, up to approximately 3 years.
To evaluate the pharmacokinetics of Peluntamig (PT217).
Time frame: Through study completion, up to approximately 3 years.
To evaluate the immunogenicity (ADA) of Peluntamig (PT217).
Time frame: Through study completion, up to approximately 3 years.
To further evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments
Time frame: Through study completion, up to approximately 3 years.
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