NCT04121442

Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors

Phase I/IIa, Non-Randomised, Open-Label Dose Escalation and Expansion Trial With Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Metastatic or Unresectable, Locally Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Buzzard Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Isunakinra - a potent Interleukin-1 receptor inhibitor - will be given to patients with solid tumors to determine safety and tolerability of three different doses. Isunakinra will then be combined with a PD-(L)1 inhibitor. Pharmacokinetics and Pharmacodynamic effects of monotherapy treatment as well as the combination will be evaluated.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Isunakinra	Isunakinra is a recombinant protein that binds to the IL1R1 and potently blocks IL-1 alpha and IL-1 beta signaling
BIOLOGICAL	PD-(L)1 Inhibitor	Monoclonal antibody targeting PD-1 or PD-L1

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-12-31
• Completion: 2024-07-15
• First posted: 2019-10-09
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study