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A Phase 1b/2a Two-Part, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers

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Trial Profile

A Phase 1b/2a Two-Part, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Jul 2024

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At a glance

  • Drugs OC-001 (Primary) ; Programmed cell death 1 receptor antagonists; Programmed cell death-1 ligand-1 inhibitors
  • Indications Advanced breast cancer; Bladder cancer; Cervical cancer; Gastric cancer; Head and neck cancer; Liver cancer; Merkel cell carcinoma; Non-small cell lung cancer; Ovarian cancer; Renal cell carcinoma; Sarcoma; Skin cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions
  • Sponsors Ocellaris Pharma

    • Most Recent Events

    • 27 Nov 2023 Planned End Date changed from 1 Nov 2022 to 30 Sep 2026.
    • 27 Nov 2023 Planned primary completion date changed from 1 Nov 2022 to 31 Mar 2026.
    • 13 Sep 2022 Results (n=15) reporting safety data and PK profiles from phase 1b portion of this trial presented at the 47th European Society for Medical Oncology Congress

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