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OncoMatch/Clinical Trials/NCT05652686

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

Is NCT05652686 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Peluntamig (PT217) and Carboplatin + Etoposide for small cell lung cancer (sclc).

Phase 1/2RecruitingPhanes TherapeuticsNCT05652686Data as of May 2026

Treatment: Peluntamig (PT217) · Carboplatin + Etoposide · Paclitaxel. · AtezolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Prostate Cancer

Neuroendocrine Tumor

Biomarker criteria

Required: DLL3 overexpression

tumor tissue...to be assessed for DLL3 expression and other biomarkers

Disease stage

Metastatic disease required

Grade: well differentiated grade 3 (Ki-67 ≥ 55%) allowed if DLL3 positive (Ki-67)

histologically or cytologically confirmed unresectable advanced or metastatic... Patients with well differentiated grade 3 neuroendocrine tumors (Ki-67 ≥ 55%) may be considered if their tumors are DLL3 positive.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy — SCLC

at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC patients

Lab requirements

Blood counts

adequate organ function confirmed at screening and within 72 hours of initiating C1D1

Kidney function

adequate organ function confirmed at screening and within 72 hours of initiating C1D1

Liver function

adequate organ function confirmed at screening and within 72 hours of initiating C1D1

Cardiac function

impaired cardiac function or significant diseases excluded; 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 excluded

Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment. Impaired cardiac function or significant diseases. 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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, California
  • Sarah Cannon Research Institute at HealthONE · Denver, Colorado
  • Sidney Kimmel Comprehensive Cancer Center at John Hopkins · Baltimore, Maryland
  • Massachusetts General Hospital · Boston, Massachusetts
  • Dana-Farber Cancer Institute · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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