NCT04900519

Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.

Detailed description

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor. The study will determine an MTD and RP2D using a conventional 3+3 study design with priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.

Conditions

• Solid Tumor
• Relapsed Solid Neoplasm
• Refractory Tumor

Interventions

Type	Name	Description
BIOLOGICAL	STI-6643	Anti-CD47 human monoclonal antibody

Timeline

• Start date: 2021-11-24
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2021-05-25
• Last updated: 2023-01-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study