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
NCT ID: NCT06827613
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2025-03-24
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 Safety Run-In: Advanced Solid Tumors
Interventions: STAR0602 + Sacituzumab Govitecan
STAR0602
solution, intravenous infusion
Sacituzumab Govitecan (SG)
intravenous infusion, 10mg/kg
Phase 2 Cohort Expansion: Advanced Solid Tumors
Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1
STAR0602
solution, intravenous infusion
Sacituzumab Govitecan (SG)
intravenous infusion, 10mg/kg
Interventions
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STAR0602
solution, intravenous infusion
Sacituzumab Govitecan (SG)
intravenous infusion, 10mg/kg
Eligibility Criteria
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Inclusion Criteria
2. Tumor Type:
* mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
* HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer
3. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
No concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.
Exclusion Criteria
* Vitiligo
* Psoriasis
* Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment
* History of Graves' disease, now euthyroid for \> 4 weeks
* Hypothyroidism managed by thyroid replacement
* Alopecia
* Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs
* Adrenal insufficiency well-controlled on replacement therapy
2. Major surgery or traumatic injury within 8 weeks before first dose of study intervention
3. Unhealed wounds from surgery or injury
4. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
5. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
6. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
7. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
8. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
9. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
10. Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed
18 Years
ALL
No
Sponsors
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Marengo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Health
Los Angeles, California, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, United States
BC Cancer
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Steven Isakoff, MD, PhD, MMSC
Role: primary
Other Identifiers
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START-002
Identifier Type: -
Identifier Source: org_study_id
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