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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: Recruiting Phase 1 study of HR+, HER2-, Advanced Breast Cancer and Triple Negative Locally Advanced Non-resectable Breast Cancer, sponsored by Marengo Therapeutics.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-03-24 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What NCT06827613 shows while recruiting
NCT06827613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for HR+, HER2-, Advanced Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06827613's enrollment target sits among peer trials
50 974th of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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