Actively Recruiting
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
Led by Marengo Therapeutics, Inc. · Updated on 2025-09-24
50
Participants Needed
8
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable disease confirmed by CT and/or MRI scans, with cutaneous or subcutaneous lesions measurable by calipers
- Diagnosis of progression or recurrence of locally advanced or metastatic triple negative breast cancer (mTNBC) or HR+/HER2- breast cancer
- Symptomatic central nervous system metastases must be treated, asymptomatic for at least 14 days, with no concurrent treatment or leptomeningeal disease
You will not qualify if you...
- History of autoimmune diseases except for vitiligo, psoriasis, certain autoimmune skin conditions not requiring systemic treatment, euthyroid Graves' disease, hypothyroidism managed by thyroid replacement, alopecia, arthritis managed without systemic therapy beyond NSAIDs, or well-controlled adrenal insufficiency
- Major surgery or traumatic injury within 8 weeks before first dose
- Unhealed wounds from surgery or injury
- Significant cardiovascular, gastrointestinal, inflammatory, or pulmonary conditions
- Active infections requiring parenteral treatment within 7 days prior to study
- Live virus vaccination within 4 weeks prior to study (inactivated influenza vaccine allowed)
- Known HIV, hepatitis B or C positive with uncontrolled disease
- Second primary invasive malignancy not in remission for at least 1 year except certain indolent cancers
- Pregnant, likely to become pregnant, or lactating women
- Treatment with more than 10 mg per day prednisone or other immune-suppressive drugs within 7 days prior to study (exceptions for certain allergic reactions); steroids for topical, ophthalmic, inhaled, or nasal use allowed
AI-Screening
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Trial Site Locations
Total: 8 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
UCLA Health
Los Angeles, California, United States, 90095
Actively Recruiting
3
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43212
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
7
BC Cancer
Vancouver, British Columbia, Canada, V5Z 1K1
Actively Recruiting
8
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
K
Kevin Chin, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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