A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers
Latest Information Update: 26 Jul 2024
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
- 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.