NCT06827613PHASE1, PHASE2Recruiting
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
Marengo Therapeutics, Inc.
Start Date
3/24/2025
Completion Date
1/1/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
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:
1. History of known autoimmune disease with exceptions of:
* 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
Interventions
DRUG
STAR0602
DRUG
Sacituzumab Govitecan (SG)
Conditions
Triple Negative Locally Advanced Non-resectable Breast CancerHR+, HER2-, Advanced Breast Cancer
Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
UCLA Health
Los Angeles, California 90095
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43212
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas 78229
United States
BC Cancer
Vancouver, British Columbia V5Z 1K1
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C4
Canada