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NCT06827613 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HR+, HER2-, Advanced Breast Cancer and Triple Negative Locally Advanced Non-resectable Breast Cancer, sponsored by Marengo Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
50
Enrollment target
8
Study locations

NCT06827613 is a Phase 1 study of HR+, HER2-, Advanced Breast Cancer and Triple Negative Locally Advanced Non-resectable Breast Cancer that is actively recruiting participants, run by Marengo Therapeutics. The registered enrollment target is 50 participants. The trial reports 8 study locations across 7 states.

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The verdict

NCT06827613, a Phase 1 study of HR+, HER2-, Advanced Breast Cancer and Triple Negative Locally Advanced Non-resectable Breast Cancer, is actively recruiting participants, sponsored by Marengo Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
8
Study locations

Study Summary

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.

Interventions

  • DRUG STAR0602
  • DRUG Sacituzumab Govitecan (SG)

Study Locations (8)

California

  • USC Norris Comprehensive Cancer Center - Los Angeles
  • UCLA Health - Los Angeles

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Tennessee

  • Sarah Cannon Research Institute - Nashville

Texas

  • UT Health San Antonio MD Anderson Cancer Center - San Antonio

British Columbia

  • BC Cancer - Vancouver

Ontario

  • Princess Margaret Cancer Centre - Toronto

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2025-03-24
Est. Completion 2028-01
Phase Phase 1

Sponsor

Marengo Therapeutics

2 total trials

What the Registry Record Tells You About NCT06827613

The ClinicalTrials.gov registry entry for NCT06827613 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marengo Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HR+, HER2-, Advanced Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which STAR0602 is the first listed.

NCT06827613 reports 8 study locations spanning 7 distinct geographic areas - top geographies include California, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT06827613 about?

NCT06827613 is a clinical study titled "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". 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 Metastati...

What is the current status of trial NCT06827613?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-03-24. Estimated completion is 2028-01.

What conditions does trial NCT06827613 study?

This clinical trial studies the following conditions: HR+, HER2-, Advanced Breast Cancer, Triple Negative Locally Advanced Non-resectable Breast Cancer.

What interventions are being tested in trial NCT06827613?

The interventions under investigation include: STAR0602 (DRUG), Sacituzumab Govitecan (SG) (DRUG).

Who is sponsoring clinical trial NCT06827613?

This trial is sponsored by Marengo Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06827613 being conducted?

This trial has 8 study locations across California, Massachusetts, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.