An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
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
Trial Status: active
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.
Inclusion Criteria
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.
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
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
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
Major surgery or traumatic injury within 8 weeks before first dose of study intervention
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
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.
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)
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06827613.
