A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 / PD-L1 Bispecific Antibody SPX- 303 in Patients With Solid Tumors
SparX Biotech(Jiangsu) Co., Ltd.
Summary
Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
Description
This study is an open-label, dose escalation study of SPX-303 monotherapy to evaluate safety and tolerability, and to identify the MTD or MAD as well as evaluate preliminary anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of various doses of SPX- 303 in patients with measurable disease who have progressed on or after prior therapy and who are not eligible or decline treatment options.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study 2. Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy 3. Patients who have progressed on or after prior therapy and who are not eligible for available treatment options 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Has at least 1 measurable…
Interventions
- BiologicalSPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody
SPX- 303 Injection
Locations (4)
- Mayo Clinic ArizonaPhoenix, Arizona
- HonorHealth Research and Innovation InstituteScottsdale, Arizona
- Mayo Clinic FloridaJacksonville, Florida
- Mayo Clinic RochesterRochester, Minnesota