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NCT05592626 · ClinicalTrials.gov record · last posted 2026-08-11

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

Study acronym: START-001
StatusRecruiting
PhasePhase 1/2
Started2023-01-04
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from the ClinicalTrials.gov record
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.

Protocol amendment history 3 changes detected by DataLookout

2026-08-12
minor
Trial sites reduced: 32 → 19 locations
2026-08-12
critical
Primary completion pushed: 2026-10 → 2027-09
2026-08-12
minor
Completion pushed: 2026-10 → 2027-09
Trial Details
NCT Number NCT05592626
Lead Sponsor Marengo Therapeutics, Inc.
Conditions Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm, Neoplasms by Site, Papillomavirus Infection, Epstein-Barr Virus Infections, Carcinoma +6 more
Enrollment 366 participants
Start Date 2023-01-04
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-11