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A Phase 1, Open-label, Dose Escalation Study of KB-PD1 in Subjects with PD‑L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies

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Trial Profile

A Phase 1, Open-label, Dose Escalation Study of KB-PD1 in Subjects with PD‑L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 29 Jun 2022

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At a glance

  • Drugs Programmed cell death protein 1 gamma-delta chimeric antigen receptor T cell therapy-Kiromic (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Colon cancer; Lung cancer; Male breast cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Renal cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Acronyms ALEXIS-PRO-1
  • Sponsors Kiromic

    • Most Recent Events

    • 21 Jun 2022 According to a Kiromic media release, clinical activation of this study expected to begin by the end of second quarter 2023.
    • 11 May 2022 According to a Kiromic media release, the Company will submit an amended Investigational New Drug Application (IND) to the FDA in the second half of 2022. There is no need proceed with the previously contemplated Type A meeting with the FDA to further address the CMC issues.
    • 13 Aug 2021 According to a Kiromic media release, company re-submit IND applications to the United States Food and Drug Administration for ALEXIS-PRO-1.

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