NCT06259552

A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: SparX Biotech(Jiangsu) Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor
• HNSCC
• RCC
• CRC

Interventions

Type	Name	Description
BIOLOGICAL	SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody	SPX- 303 Injection

Timeline

• Start date: 2024-03-20
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-02-14
• Last updated: 2024-09-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study