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NCT05652686 | RECRUITING | Small Cell Lung Cancer (SCLC)

A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
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.

Condition or disease

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)

Intervention/treatment

Peluntamig (PT217)

Carboplatin + Etoposide

Paclitaxel.

Atezolizumab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 203 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2023-09-05
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2028-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. NECs that have transformed from NSCLC are not eligible. Part A: Patients with histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC). Patients with tumors that are of mixed histology are eligible only if neuroendocrine carcinoma/small cell cancer component is predominant and represents at least 50% of the overall tumor tissue.
  • 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 and EP-NEC eligible for first-line (1L) CE treatment, or 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 second line (2L) CE treatment.
    • Cohort C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.
    • Part D:
    • * Cohort D1: will include second-line (2L) patients with LCNEC, EP-NEC or ES-SCLC that have progressed/relapsed from their first-line treatment that may have included an ICI.
    • * Cohort D2: will include first-line (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 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. Biopsy must be excisional, incisional, or core needle. This biopsy may not be done if the biopsy poses a risk to the patient and/or per the Investigator's discretion.
    • 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.
    • Key Exclusion Criteria
    • 1. Women who are pregnant or lactating.
    • 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) 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 enrollment.
    • 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.
    • A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)

    Location Details

    NCT05652686

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    How to Participate

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    Locations

    RECRUITING

    United States, California

    City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, United States, 91010

    RECRUITING

    United States, Colorado

    Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, United States, 80218

    RECRUITING

    United States, Maryland

    Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, United States, 21287

    RECRUITING

    United States, Massachusetts

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    RECRUITING

    United States, Massachusetts

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02215

    RECRUITING

    United States, Missouri

    Washington University School of Medicine (Siteman Cancer Center)

    Saint Louis, Missouri, United States, 63108

    RECRUITING

    United States, North Carolina

    University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States, 27599

    RECRUITING

    United States, Oklahola

    Sarah Cannon Research Institute University of Oklahoma

    Ololama City, Okholohan, United States, 73104

    RECRUITING

    United States, Oregon

    Providence Portland Medical Center

    Portland, Oregon, United States, 97213

    RECRUITING

    United States, Texas

    Mays Cancer Center / University of Texas, San Antonio

    San Antonio, Texas, United States, 78229

    RECRUITING

    United States, Virginia

    NEXT Virginia

    Fairfax, Virginia, United States, 22031