Phase 12 Study of Peluntamig PT217 Alone and with Chemotherapy or Immunotherapy in Adults with DLL3-Positive Neuroendocrine Carcinomas

What this Trial Is About

Researchers are evaluating Peluntamig PT217, a bispecific antibody targeting DLL3 and CD47, in patients with various neuroendocrine carcinomas that express DLL3. This first-in-human, Phase 12, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig both alone and combined with chemotherapy or immune checkpoint inhibitors. The study includes patients with advanced or metastatic small cell lung cancer, large cell neuroendocrine carcinoma, extrapulmonary neuroendocrine carcinoma, and other related tumors. The study has several parts Part A uses a standard 33 dose escalation design to determine the recommended dose for expansion. Part B involves dose expansion cohorts after dose levels are established. Part C includes substudies combining Peluntamig with chemotherapy agents such as carboplatin, etoposide, paclitaxel, lurbinectedin, irinotecan, and topotecan. Part D evaluates Peluntamig combined with atezolizumab alone or with chemotherapy. Treatments are given according to the study phase and patient eligibility for specific substudies. Participants will be monitored throughout the study for safety, tolerability, and response to treatment, with assessments including tumor measurements by RECIST criteria, organ function tests, and biomarker analysis from tumor samples. Researchers will track pharmacokinetics and immunogenicity of Peluntamig. The study aims to determine effective dosing and evaluate response rates over approximately three years, with ongoing safety and efficacy evaluations.

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