Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Trial status:Recruiting
Trial ID:
ONC-392-001
NCT ID:
NCT04140526
EudraCT ID:
N/A
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.
OncoC4, Inc.
Recruiting

Trial Details

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

Medical Condition
  • Lung Cancer
  • Solid Tumors
  • Skin Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Colorectal Cancer
  • Sarcoma
  • Prostate Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Oncology
  • Esophageal Cancer
  • Stomach Cancer
  • Cervical Cancer
  • Salivary Gland Cancer
  • Bladder Cancer
    • Trial Drug
  • ONC-392
    • See more
  • Pembrolizumab
  • Docetaxel
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    733
    Estimated Trial Date
    Sep 2020 - Jun 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Highlands Oncology Group
    Springdale, Arkansas, United States, 72762
    Status
    Recruiting
    Location
    University of California at Davis
    Davis, California, United States, 95817
    Status
    Recruiting
    Location
    The Oncology Institute of Hope and Innovation
    Downey, California, United States, 90241
    Status
    Recruiting
    Location
    City of Hope Cancer Center
    Duarte, California, United States, 91010
    Status
    Recruiting
    Location
    University of Colorado Hospital
    Aurora, Colorado, United States, 80045
    Status
    Recruiting
    Location
    Nuvance Health
    Norwalk, Connecticut, United States, 06856
    Status
    Recruiting