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A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

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Trial Profile

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Jul 2024

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At a glance

  • Drugs Cosibelimab (Primary)
  • Indications Cancer; Colorectal cancer; Endometrial cancer; Head and neck cancer; Hodgkin's disease; Laryngeal cancer; Malignant melanoma; Merkel cell carcinoma; Mesothelioma; Mouth neoplasm; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Pharyngeal neoplasms; Renal cell carcinoma; Skin cancer; Small cell lung cancer; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Sponsors Checkpoint Therapeutics

    • Most Recent Events

    • 25 Jul 2024 According to a Checkpoint Therapeutics media release, U.S. Food and Drug Administration (FDA) has accepted for review resubmission of Biologics License Application (BLA) for cosibelimab. The resubmission has been accepted as a complete response to the FDA's December 2023 complete response letter (CRL) and the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of Dec 28, 2024.
    • 02 Jul 2024 According to a Checkpoint Therapeutics media release, company has completed the resubmission of its Biologics License Application to the U.S. Food and Drug Administration for cosibelimab.
    • 24 Jun 2024 According to a Checkpoint Therapeutics media release,company announced that it has reached alignment with the FDA on its BLA resubmission strategy for cosibelimab.plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma.

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