A Study of Peluntamig (PT217) in Patients with Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
- Conditions
- Small Cell Lung Cancer (SCLC)Large Cell Neuroendocrine Cancer (LCNEC)Neuroendocrine Prostate Cancer (NEPC)Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)Neuroendocrine Carcinomas (NEC)Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
- Interventions
- Registration Number
- NCT05652686
- Lead Sponsor
- Phanes Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 203
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Dose Escalation Peluntamig (PT217) A standard 3+3 dose escalation design will be employed. Part B: Dose Expansion Peluntamig (PT217) Part B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D. Part C: Chemotherapy Combination Therapy Peluntamig (PT217) Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy. Part C: Chemotherapy Combination Therapy Carboplatin + Etoposide Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy. Part C: Chemotherapy Combination Therapy Paclitaxel. Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy. Part D: ICI Combination Therapy Peluntamig (PT217) In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy. Part D: ICI Combination Therapy Carboplatin + Etoposide In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy. Part D: ICI Combination Therapy Atezolizumab In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of Peluntamig (PT217). Through study completion. To determine the dose-limiting toxicity (DLT) of Peluntamig (PT217). Through study completion. To determine the maximum tolerated dose (MTD) of Peluntamig (PT217) if reached. Through study completion. To determine recommended dose for expansion (RDE) of Peluntamig (PT217). Through study completion.
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of Peluntamig (PT217). Through study completion. To evaluate the immunogenicity (ADA) of Peluntamig (PT217). Through study completion. To evaluate the preliminary efficacy of Peluntamig (PT217). Through study completion.
Trial Locations
- Locations (7)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Sarah Cannon Research Institute University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
Mays Cancer Center / University of Texas, San Antonio
🇺🇸San Antonio, Texas, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States