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: 21 Aug 2026

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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

11 Aug 2026 Planned number of patients changed from 365 to 366.
11 Aug 2026 Planned End Date changed from 1 Oct 2026 to 1 Sep 2027.
11 Aug 2026 Planned primary completion date changed from 1 Oct 2026 to 1 Sep 2027.

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