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Interleukin-1 receptor inhibitor

Isunakinra + PD-1/PD-L1 Inhibitor for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Buzzard Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have metastatic or unresectable locally advanced malignant solid tumor

Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of this agent in patients < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial will test the safety and tolerability of a new cancer drug, and then study how well it works when combined with another cancer drug.

Who is the study for?

Adults with advanced solid tumors that can't be surgically removed or have spread, who've tried at least one treatment without success. They must have normal organ function and not be pregnant, breastfeeding, or have serious illnesses that could interfere with the trial. Stable brain metastasis patients are eligible; those with active autoimmune diseases or on steroids (except for certain conditions) cannot join.Check my eligibility

What is being tested?

The trial is testing Isunakinra alone in three different doses to see how safe it is and how the body reacts to it. Afterward, Isunakinra will be combined with a PD-(L)1 inhibitor to study the effects of this combination therapy on patients' tumors.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible allergic reactions due to drug components similarity, and general side effects like fatigue or digestive issues which are common in treatments affecting the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread or cannot be removed by surgery.

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I am 18 years old or older.

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My blood tests and organ functions are normal.

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I am fully active and can carry on all pre-disease activities without restriction.

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My kidney function tests are within normal limits.

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My cancer can be measured using specific imaging techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who experience DLTs

Proportion of patients who experience decrease of IL-6 or hsCRP by >20%

Secondary outcome measures

Overall survival

Percent of individuals who experience radiographic response

Progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Isunakinra monotherapy and in combination w PD-(L)1 InhibitorExperimental Treatment2 Interventions

Patients will receive specified dose of Isunakinra as monotherapy for three weeks, followed by combination with a PD-(L)1 inhibitor

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Buzzard PharmaceuticalsLead Sponsor

Baylor Research InstituteOTHER

200 Previous Clinical Trials

203,201 Total Patients Enrolled

Maarten de Chateau, MD, PhDStudy DirectorBuzzard Pharmaceuticals

1 Previous Clinical Trials

27 Total Patients Enrolled

Media Library

Isunakinra (Interleukin-1 receptor inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04121442 — Phase 1 & 2

Solid Tumors Research Study Groups: Isunakinra monotherapy and in combination w PD-(L)1 Inhibitor

Solid Tumors Clinical Trial 2023: Isunakinra Highlights & Side Effects. Trial Name: NCT04121442 — Phase 1 & 2

Isunakinra (Interleukin-1 receptor inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04121442 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this clinical trial?

"According to the data available on clinicaltrials.gov, this experiment is currently enrolling participants and was initially posted in September 2020 with its most recent update occurring on July 2021."

Answered by AI

Can you provide a compendium of investigations surrounding Isunakinra?

"Presently, one clinical trial for Isunakinra is actively in progress and none are currently at Phase 3. This research project has a presence in Dallas, Texas with an additional site operating studies."

Answered by AI

What is the current capacity of this research study?

"Affirmative. According to clinicaltrials.gov, this medical trial that was first unveiled on September 1st 2020 is currently recruiting patients. 25 volunteers are required from a single site."

Answered by AI

Is this venture unprecedented in its methodology?

"At present, Isunakinra is being tested in a single location as part of an ongoing clinical study. This experiment was initiated by Buzzard Pharmaceuticals in 2020 and included 25 participants who successfully completed the Phase 1 & 2 assessment process. 5 additional trials have been conducted since then."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

Design of a Superior Cytokine Antagonist for Topical Ophthalmic Use

Hou, Jinzhao, Sharon A. Townson, Joseph T. Kovalchin, Allyson Masci, Olga Kiner, Yanqun Shu, Bracken M. King, et al.. 2013. “Design of a Superior Cytokine Antagonist for Topical Ophthalmic Use”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1217996110.

Eye & Contact Lens: Science & Clinical PracticeJournal

Preclinical Development of EBI-005: An IL-1 Receptor-1 Inhibitor for the Topical Ocular Treatment of Ocular Surface Inflammatory Diseases

Kovalchin, Joseph, Bracken King, Allyson Masci, Elizabeth Hopkins, Jeremy Fry, Jay Hou, Christian Li, et al.. 2018. “Preclinical Development of EBI-005: An IL-1 Receptor-1 Inhibitor for the Topical Ocular Treatment of Ocular Surface Inflammatory Diseases”. Eye & Contact Lens: Science & Clinical Practice. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/icl.0000000000000414.

clinicaltrials.govStudy

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

2020. "Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04121442.