NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma

Trial status:Recruitment Complete
Study Identifier:
NTC-001
ClinicalTrials.gov Identifier:
NCT04625205
EudraCT Identifier:
2019-003908-13
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech US Inc.
Recruitment Complete

Trial details

Medical Condition
  • Skin Cancer
    • Study Drug
  • Biological: NEO-PTC-01
  • Drug: IL-2
  • Drug: αPD-1 therapy
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years
    Estimated Trial Date
    Dec 2020 - Oct 2025

    Protocol summary

    Study to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient's tumor and the tumor microenvironment. The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion). The dose-finding part of the study will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned, a cohort to investigate NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to further define the safety of NEO-PTC-01.

    Trial locations

    Location
    Status
    Location
    Universitair Ziekenhuis Brussel
    Brussel, Belgium, 1090
    Status
    Location
    Netherlands Cancer Institute - Antoni van Leeuwenhoek
    Amsterdam, Netherlands, 1066 CX
    Status
    Location
    Hospital Universitario Valle de Hebrón
    Barcelona, Spain, 08035
    Status