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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: 01 Dec 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

  • 07 Nov 2025 According to a Marengo Therapeutics media release, interim results were presented in a late-breaking clinical oral presentation at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting.
  • 07 Nov 2025 Interim Results (As of the July 15, 2025)presented in the Marengo Therapeutics Media Release
  • 31 Oct 2025 According to a Marengo Therapeutics media release, the company present initial Phase 2 monotherapy results from this study in a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, taking place November 5-9, 2025, in National Harbor, Maryland.

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