NCT04294576

Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors

First-in-human (FIH), Open-Label, Phase 1a (Dose Escalation)/Phase 1b (Expansion Cohort) Trial of BJ-001 as a Single Agent and in Combination With Pembrolizumab in Patients With Locally Advanced/Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: BJ Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab in adult patients with Locally Advanced/Metastatic Solid Tumors

Conditions

• Locally Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	BJ-001	BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.
DRUG	Pembrolizumab	BJ-001 dosed via SC injection in combination with Pembrolizumab One cycle is 6 weeks.

Timeline

• Start date: 2019-12-04
• Primary completion: 2024-04-29
• Completion: 2024-10-22
• First posted: 2020-03-04
• Last updated: 2023-11-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study