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Solid Tumor, AdultPhase 1/2NCT04121442

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

A Phase 1/2 study testing Isunakinra and PD-(L)1 Inhibitor in people with Solid Tumor, Adult, run by Buzzard Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
Isunakinra and PD-(L)1 Inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 15 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have:
  • Metastatic or unresectable locally advanced malignant solid tumor.
  • Histologic confirmation.
  • The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1) and irRC.
  • Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease (with or without PD-1 inhibitors), with no available therapy likely to convey clinical benefit, or not be candidates for therapy of proven efficacy for their disease.
  • There should be a minimum of 2 weeks from any prior chemotherapy, immunotherapy and/or radiation and 4 weeks washout period for immunotherapy. Patients with prostate cancer on hormone deprivation therapy may continue that therapy while on study.
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  • Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy (for example, alopecia is not clinically significant). Typically, this approximates 3-4 weeks for patients who most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C, for which 6 weeks is needed for recovery.
  • 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.
  • ECOG performance status ≤ 1
  • Patients must have normal organ and hematologic function as defined below:
  • Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL/min.
  • ALT and AST ≤ 3x the upper limits of normal.
  • Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.
  • Hematological eligibility parameters (within 16 days of starting therapy):
  • Granulocyte count ≥ 1,500/mm3
  • Platelet count ≥ 75.000/mm3
  • Patients must have baseline pulse oximetry > 90% on room air.

Who cannot join

  • Pregnant women or women presently breast-feeding their children are excluded due to unknown risks to a developing fetus or infant, confirmed by negative pre-treatment serum pregnancy test.
  • Concurrent treatment for cancer, with specific exceptions noted in inclusion criteria.
  • Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
  • Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Active autoimmune diseases requiring treatment. However, patients with vitiligo, alopecia, or clinically stable autoimmune endocrine disease who are on appropriate replacement therapy (if such therapy is indicated) are eligible.
  • Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited pharmacologic doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent iv contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed.
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  • Patients who are receiving any other investigational agents within 28 days before start of study treatment.
  • Patients with untreated central nervous system metastases or local treatment of brain metastases within the last 6 months. Patients with stable brain metastasis for 6 months post-intervention are eligible.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
  • Serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
  • HIV-positive patients are ineligible because of the potential for decreased immune response.
  • Patients unwilling to use adequate contraception (defined as hormonal or barrier method or abstinence) prior to study entry are excluded. If the patient needs to be on adequate contraception, contraception must start before study entry and continue for 3 months after completion of study therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Charles A. Simmons Cancer Center

    Dallas, Texas, 75246

Other trials in United States

About this study

Official title: 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

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.

Being tested
Isunakinra, PD-(L)1 Inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsunakinraBiological

    Also called EBI-005

    Isunakinra is a recombinant protein that binds to the IL1R1 and potently blocks IL-1 alpha and IL-1 beta signaling

  • PD-(L)1 InhibitorBiological

    Monoclonal antibody targeting PD-1 or PD-L1

Study groups in NCT04121442
Study groupRoleWhat they receive
Isunakinra monotherapy and in combination w PD-(L)1 InhibitorExperimentalPatients will receive specified dose of Isunakinra as monotherapy for three weeks, followed by combination with a PD-(L)1 inhibitor
Receives: Biological: Isunakinra; Biological: PD-(L)1 Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who experience DLTs

    The primary endpoint of this study is the proportion of patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 21 days following the first dose of Isunakinra and 28 days following addition of PD1-PDL1 inhibitor

    Measured: From baseline to 49 days of treatment

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

    Optimal Biological Dose (OBD) as indicated by changes in IL-6 and hsCRP plasma levels.

    Measured: From baseline to 49 days of treatment

Secondary outcomes (3)

  1. Percent of individuals who experience radiographic response

    Overall response rate (ORR) by RECIST 1.1

    Measured: Two years

  2. Progression-free survival (PFS)

    Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason.

    Measured: Two years

  3. Overall survival

    Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2019
  2. Study start1 Sep 2020
  3. Primary completion31 Dec 2023
  4. Study completion15 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04121442
Sponsor's protocol ID
BUZ01CD101
Status last verified
Aug 2024
First submitted
7 Oct 2019
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hou J, Townson SA, Kovalchin JT, Masci A, Kiner O, Shu Y, King BM, Schirmer E, Golden K, Thomas C, Garcia KC, Zarbis-Papastoitsis G, Furfine ES, Barnes TM. Design of a superior cytokine antagonist for topical ophthalmic use. Proc Natl Acad Sci U S A. 2013 Mar 5;110(10):3913-8. doi: 10.1073/pnas.1217996110. Epub 2013 Feb 19.

    PubMed 23431173

  • Kovalchin J, King B, Masci A, Hopkins E, Fry J, Hou J, Li C, Tenneson K, Weber S, Wolfe G, Collins K, Furfine ES. Preclinical Development of EBI-005: An IL-1 Receptor-1 Inhibitor for the Topical Ocular Treatment of Ocular Surface Inflammatory Diseases. Eye Contact Lens. 2018 May;44(3):170-181. doi: 10.1097/ICL.0000000000000414.

    PubMed 28727604

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Isunakinra and PD-(L)1 Inhibitor in people with Solid Tumor, Adult, run by Buzzard Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who experience DLTs (time frame: From baseline to 49 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04121442, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.

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