RecruitingPhase 1Phase 2NCT05652686

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

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)

Sponsor

Phanes Therapeutics

Enrollment

203 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer ( SCLC )Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)Neuroendocrine Carcinomas (NEC)Large Cell Neuroendocrine Cancer (LCNEC)Neuroendocrine Prostate Cancer (NEPC)Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called peluntamig (PT217) in patients with neuroendocrine carcinomas — aggressive cancers that include small cell lung cancer and similar tumors — that express a protein called DLL3. The drug is designed to engage the immune system to attack DLL3-positive cancer cells. **You may be eligible if...** - You have confirmed small cell lung cancer (SCLC), large cell neuroendocrine carcinoma, or a similar neuroendocrine tumor that has spread or cannot be removed with surgery - Prior treatment has not worked or is no longer working - Your tumor tests positive for DLL3 **You may NOT be eligible if...** - Your cancer transformed from non-small cell lung cancer (NSCLC) - You have significant immune system disorders or are on strong immunosuppressive drugs - You have uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPeluntamig (PT217)

A bispecific antibody (bsAb) against DLL3 and CD47.

DRUGCarboplatin + Etoposide

Administered per Standard of Care.

DRUGPaclitaxel.

Administered per Standard of Care.

DRUGAtezolizumab

Administered per Standard of Care.

Locations(12)

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

View Full Details on ClinicalTrials.gov

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NCT05652686

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