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A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

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Trial Profile

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs Invikafusp alfa (Primary)
  • Indications Anal cancer; Cervical cancer; Colorectal cancer; Merkel cell carcinoma; Non-small cell lung cancer; Oropharyngeal cancer; Ovarian cancer; Penile cancer; Prostate cancer; Solid tumours; Triple negative breast cancer; Vulval disorders; Vulvovaginal cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms START-001
  • Sponsors Marengo Therapeutics

    • Most Recent Events

    • 25 Mar 2025 According to a Marengo Therapeutics media release, updated clinical data from this study will be presented at the American Association of Cancer Research (AACR) Annual Meeting taking place April 26-30, 2025, in Chicago, Illinois.
    • 08 Jan 2025 According to a Marengo Therapeutics media release, the company expects to report additional efficacy results later this year.
    • 08 Jan 2025 According to a Marengo Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to invikafusp alfa (STAR0602) based on the encouraging results from Marengo's first-in-human Phase 1 clinical study of invikafusp alfa.

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