Actively Recruiting
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
Led by Phanes Therapeutics · Updated on 2025-09-23
203
Participants Needed
12
Research Sites
256 weeks
Total Duration
On this page
Sponsors
P
Phanes Therapeutics
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients with unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC)
- Tumors with mixed histology eligible only if neuroendocrine carcinoma or small cell cancer component is predominant (at least 50% of tumor tissue)
- Well differentiated grade 3 neuroendocrine tumors with Ki-67 2 55% may be included if DLL3 positive
- Patients may have progressed after standard treatments or have no available or tolerated treatment options
- Patients in various cohorts based on treatment line eligibility and prior therapies as described (Part A, B, C, D cohorts)
- Ability to provide formalin-fixed, paraffin-embedded tumor tissue for DLL3 expression and biomarker assessment
- ECOG performance status of 0 or 1
- Adequate organ function confirmed within 72 hours before starting Peluntamig (PT217)
You will not qualify if you...
- Pregnancy or lactation
- Women of child-bearing potential not using adequate birth control
- Autoimmune disease requiring systemic treatment within the past 12 months
- Recent treatment with systemic immunostimulatory agents within 4 weeks or 5 drug half-lives
- Need for systemic corticosteroids or immunosuppressive medications (>=10 mg prednisone or equivalent) within 14 days before study drug or anticipated use during treatment
- History of Grade 2 3 immune-related events such as pneumonitis, interstitial lung disease, myocarditis
- Treatment with therapeutic antibiotics within 2 weeks before study treatment
- Untreated or progressing brain or central nervous system metastases
- Impaired cardiac function or significant diseases
- For Part D only: uncontrolled hypercalcemia and significant cardiovascular disease within 3 months prior to treatment
- Prior hemolytic anemia or Evans Syndrome in the last 3 months
- Grade 2 3 neuropathy
- Current treatment with therapeutic doses of warfarin or coumarin-derivative anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Washington University School of Medicine (Siteman Cancer Center)
St Louis, Missouri, United States, 63108
Actively Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
10
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
11
Mays Cancer Center / University of Texas, San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
12
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
P
Phanes Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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