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

Description

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)

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Small Cell Lung Cancer (SCLC)
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Oklahoma City

Sarah Cannon Research Institute University of Oklahoma, Oklahoma City, Oklahoma, United States, 73104

San Antonio

Mays Cancer Center / University of Texas, San Antonio, San Antonio, Texas, United States, 78229

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Phanes Therapeutics,

    Study Record Dates

    2028-08