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 (NCT06827613)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (19 items).
Location: USC Norris Comprehensive Cancer Center โ Los Angeles, California
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- Unhealed wounds from surgery or injury
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (8 Sites)
- USC Norris Comprehensive Cancer Center โ Los Angeles, California
- UCLA Health โ Los Angeles, California
- Massachusetts General Hospital Cancer Center โ Boston, Massachusetts
- Ohio State University Comprehensive Cancer Center โ Columbus, Ohio
- Sarah Cannon Research Institute โ Nashville, Tennessee
- UT Health San Antonio MD Anderson Cancer Center โ San Antonio, Texas
- BC Cancer โ Vancouver, British Columbia
- Princess Margaret Cancer Centre โ Toronto, Ontario
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.