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

NCT04121442 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Baylor Research Institute

    collaborator OTHER

  • Buzzard Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Maarten de Chateau, MD, PhD · Buzzard Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-12-31
Completion
2024-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121442 on ClinicalTrials.gov