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 (START-002)
Marengo Therapeutics, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 concur…
Interventions
- DrugSTAR0602
solution, intravenous infusion
- DrugSacituzumab Govitecan (SG)
intravenous infusion, 10mg/kg
Locations (8)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- UCLA HealthLos Angeles, California
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- Sarah Cannon Research InstituteNashville, Tennessee
- UT Health San Antonio MD Anderson Cancer CenterSan Antonio, Texas