A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
NCT ID: NCT05652686
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
203 participants
INTERVENTIONAL
2023-09-05
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Dose Escalation
A standard 3+3 dose escalation design will be employed.
Peluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
Part B: Dose Expansion
Part B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D.
Peluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
Part C: Chemotherapy Combination Therapy
Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy.
Peluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
Carboplatin + Etoposide
Administered per Standard of Care.
Paclitaxel.
Administered per Standard of Care.
Part D: ICI Combination Therapy
In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.
Peluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
Carboplatin + Etoposide
Administered per Standard of Care.
Atezolizumab
Administered per Standard of Care.
Interventions
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Peluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
Carboplatin + Etoposide
Administered per Standard of Care.
Paclitaxel.
Administered per Standard of Care.
Atezolizumab
Administered per Standard of Care.
Eligibility Criteria
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Inclusion Criteria
Patients may have progressed after standard of care treatments (at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC patients) or other treatment options, or for whom treatment is not available or not tolerated.
Part B: Patients must meet the same criteria in Part A, C or D.
Part C:
• Cohort C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum sensitive (defined as patients who experienced disease progression at least 90 days after their last platinum based chemotherapy) and are eligible for CE treatment rechallenge.
Cohort C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.
Part D:
* Cohort D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC that have progressed/relapsed from their first-line treatment that may have included an ICI.
* Cohort D2: will include 1L ES-SCLC patients that have completed their induction therapy with carboplatin and etoposide plus atezolizumab and are eligible to continue with atezolizumab. These patients must have either stable disease or partial response prior to enrollment.
* Cohort D3: will include 1L ES-SCLC patients that are treatment naïve or have received C1D1/2/3 and are eligible for treatment with CE plus atezolizumab.
2. Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably a newly acquired biopsy, or if not possible, archival tissue) to be assessed for DLL3 expression and other biomarkers.
3. ECOG performance status of 0 or 1.
4. Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment.
Exclusion Criteria
2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.
3. Autoimmune disease requiring systemic treatment within the past twelve months.
4. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2, and excluding ICIs) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment with Peluntamig (PT217).
5. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications (≥ 10 mg prednisone, or equivalent) within 14 days prior to study drug Peluntamig (PT217), or anticipation of need for systemic immunosuppressive medication during study drug Peluntamig (PT217).
6. Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.
7. Treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment with Peluntamig (PT217).
8. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 14 days are eligible for treatment.
9. Impaired cardiac function or significant diseases.
10. For Part D only, uncontrolled hypercalcemia.
11. For Part D only, significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
12. Prior hemolytic anemia or Evans Syndrome in the last 3 months.
13. Patients who have Grade ≥ 3 neuropathy.
14. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants .
Additional criteria may apply.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Phanes Therapeutics
INDUSTRY
Responsible Party
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Locations
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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine (Siteman Cancer Center)
St Louis, Missouri, 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
Providence Portland Medical Center
Portland, Oregon, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Mays Cancer Center / University of Texas, San Antonio
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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PT217X1101
Identifier Type: -
Identifier Source: org_study_id
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