RECRUITING

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

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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)DLL3DLL3 expressing tumorsLung cancerSCLCLCNECNEPCGEP-NECSmall Cell Lung CancerLarge cell neuroendocrine cancerNeuroendocrine prostate cancerGastroenteropancreatic neuroendocrine carcinomaNeuroendocrine carcinomaExtrapulmonary neuroendocrine carcinomaEP-NECCD47

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-09-05
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05652686

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Phanes Therapeutics
CONTACT
858-766-0852
clinical-trials@phanestx.com

Study Locations (Sites)

Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Mays Cancer Center / University of Texas, San Antonio
San Antonio, Texas, 78229
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Phanes Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-05
Study Completion Date2028-08

Study Record Updates

Study Start Date2023-09-05
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • DLL3
  • DLL3 expressing tumors
  • Lung cancer
  • SCLC
  • LCNEC
  • NEPC
  • GEP-NEC
  • Small Cell Lung Cancer
  • Large cell neuroendocrine cancer
  • Neuroendocrine prostate cancer
  • Gastroenteropancreatic neuroendocrine carcinoma
  • Neuroendocrine carcinoma
  • Extrapulmonary neuroendocrine carcinoma
  • EP-NEC
  • CD47

Additional Relevant MeSH Terms

  • 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)