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

NCT05652686 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • 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)

Interventions

DRUG

Peluntamig (PT217)

A bispecific antibody (bsAb) against DLL3 and CD47.

DRUG

Carboplatin + Etoposide

Administered per Standard of Care.

DRUG

Paclitaxel.

Administered per Standard of Care.

DRUG

Atezolizumab

Administered per Standard of Care.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2027-12-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652686 on ClinicalTrials.gov