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NCT06827613 · ClinicalTrials.gov record · last posted 2025-09-24

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

Study acronym: START-002
StatusRecruiting
PhasePhase 1/2
Started2025-03-24
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2025-02-10; most recent amendment 2025-09-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-04-07
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT06827613
Lead Sponsor Marengo Therapeutics, Inc.
Conditions Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
Enrollment 50 participants
Start Date 2025-03-24
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-24