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Interleukin Inhibitor

Isunakinra + Pembrolizumab for Colorectal Cancer

Phase 2
Waitlist Available
Research Sponsored by Buzzard Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have ECOG performance status ≤ 1
Subjects must have histologically or cytologically confirmed adenocarcinoma of the colon or the rectum with specific molecular characteristics
Must not have
Serious or uncontrolled intercurrent illness
Patients unwilling to use adequate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to enroll patients with colorectal cancer that is at an advanced stage. The tumor must have specific genetic characteristics and patients must have already received standard treatments. The study will test a new type

Who is the study for?
This trial is for individuals with advanced or metastatic colorectal cancer that's microsatellite stable (MSS), has a high tumor mutational burden (TMB-H), and KRAS mutation. Participants must have tried all approved treatments already.
What is being tested?
The study tests isunakinra, a new immunotherapy, alone and combined with Pembrolizumab, an existing immunotherapy. The goal is to see if adding isunakinra can make resistant tumors respond to treatment.
What are the potential side effects?
While specific side effects are not listed here, common ones for immunotherapies like Isunakinra and Pembrolizumab include fatigue, skin reactions, flu-like symptoms, appetite changes, and potential immune-related organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my self-care activities without assistance.
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My colon or rectum cancer has been confirmed by lab tests and has specific genetic features.
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I have tried at least one treatment for my cancer after it spread.
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My blood tests and organ functions are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious or uncontrolled illnesses.
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I am unwilling to use birth control.
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I have brain metastases that haven't been treated or were recently treated.
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I am HIV-positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PFS
Safety

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: combination immunotherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Buzzard PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
~13 spots leftby Jun 2026
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