An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1/2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)
Summary
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.
Arms & interventions
- DrugPeluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
- DrugCarboplatin + Etoposide
Administered per Standard of Care.
- DrugPaclitaxel.
Administered per Standard of Care.
- DrugAtezolizumab
Administered per Standard of Care.
Outcome measures
Primary
To determine the dose-limiting toxicity (DLT) of Peluntamig (PT217).
Time frame: Through study completion.
To determine the maximum tolerated dose (MTD) of Peluntamig (PT217) if reached.
Time frame: Through study completion.
To determine recommended dose for expansion (RDE) of Peluntamig (PT217).
Time frame: Through study completion.
To evaluate the safety and tolerability of Peluntamig (PT217).
Time frame: Through study completion.
To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments
Time frame: Through study completion
Secondary
To evaluate the pharmacokinetics of Peluntamig (PT217).
Time frame: Through study completion.
To evaluate the immunogenicity (ADA) of Peluntamig (PT217).
Time frame: Through study completion.
To further evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments
Time frame: Through study completion.
Eligibility criteria
Study locations (12)
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Washington University School of Medicine (Siteman Cancer Center)
St Louis, Missouri, 63108
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, 73104
Providence Portland Medical Center
Portland, Oregon, 97213
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Mays Cancer Center / University of Texas, San Antonio
San Antonio, Texas, 78229
NEXT Virginia
Fairfax, Virginia, 22031