Actively Recruiting
An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1/2 Study With Peluntamig (PT217) Followed by Key Chemotherapy and/or Checkpoint Inhibitor Combination in Patients With DLL3-Expressing Neuroendocrine Carcinomas (SKYBRIDGE)
Led by Phanes Therapeutics · Updated on 2025-09-23
203
Participants Needed
12
Research Sites
34 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
Researchers are studying Peluntamig (PT217), a bispecific antibody targeting DLL3 and CD47, in patients with neuroendocrine carcinomas expressing DLL3. This first-in-human, Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of Peluntamig alone and combined with chemotherapy or immune checkpoint inhibitors. The study focuses on advanced or metastatic small cell lung cancer, large cell neuroendocrine carcinoma, and other related neuroendocrine tumors. The study uses a dose escalation design to find the recommended dose for expansion and includes multiple parts: Part A evaluates dose escalation; Part B expands the dose cohort; Part C tests Peluntamig with chemotherapy combinations; and Part D evaluates Peluntamig with the immune checkpoint inhibitor atezolizumab, alone or with chemotherapy. Chemotherapy drugs include carboplatin, etoposide, and paclitaxel, administered per standard care. Participants will be closely monitored throughout the study, including assessments of dose-limiting toxicities, maximum tolerated dose, safety, and treatment effects. Researchers will collect tumor tissue samples to confirm DLL3 expression and monitor organ function, immune responses, and pharmacokinetics. The trial includes ongoing evaluation during treatment and through study completion, with safety and efficacy outcomes assessed to guide further development of Peluntamig. The total duration varies based on treatment response and study phase.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer, large cell neuroendocrine carcinoma of the lung, or extrapulmonary neuroendocrine carcinoma
- Tumors with mixed histology are eligible only if the neuroendocrine carcinoma or small cell cancer component is predominant and represents at least 50% of the tumor
- Well differentiated grade 3 neuroendocrine tumors with Ki-67 ≥ 55% may be included if DLL3 positive
- Patients may have progressed after at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitors, or have no other treatment options or intolerance
- Ability to provide a tumor tissue sample for DLL3 expression and biomarker assessment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function confirmed within 72 hours before starting Peluntamig treatment
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Women of child-bearing potential not using adequate birth control
- Autoimmune disease requiring systemic treatment within the past 12 months
- Treatment with systemic immunostimulatory agents within 4 weeks before study treatment, excluding immune checkpoint inhibitors
- Need for systemic corticosteroids or immunosuppressive medications (≥10 mg prednisone or equivalent) within 14 days before treatment
- History of Grade ≥ 3 immune-related events like pneumonitis, interstitial lung disease, or myocarditis
- Use of therapeutic oral or intravenous antibiotics within 2 weeks before treatment
- Untreated or progressing brain or central nervous system metastases
- Impaired cardiac function or significant heart disease
- For Part D only: uncontrolled hypercalcemia or significant cardiovascular disease within 3 months
- Prior hemolytic anemia or Evans Syndrome within last 3 months
- Grade ≥ 3 neuropathy
- Current treatment with therapeutic doses of warfarin or other coumarin anticoagulants
- Additional unspecified criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of dose escalation until recommended dose for expansion is identified
Participants receive Peluntamig (PT217) alone to determine dose escalation and maximum tolerated dose.
Multiple visits for dose escalation assessments
Duration - Until disease progression or unacceptable toxicity
Participants receive Peluntamig (PT217) as monotherapy or in combination with chemotherapy and/or immune checkpoint inhibitors.
Regular visits for treatment administration and monitoring
Duration - Up to study completion
Participants are monitored for safety and efficacy outcomes after treatment ends.
Periodic visits for safety and efficacy assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here