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RECRUITING Phase 2

Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)

NCT06634875 · View on ClinicalTrials.gov ↗

Study Summary

This study will enroll patients with colorectal cancer that is locally advanced or metastatic. The tumor must be microsatellite stable (MSS), have a tumor mutational burden that is high (TMB-H) and be kras mutated. Patients must have been treated with available approved treatments already. In this study the investigators are testing a new type of immunotherapy, the potent IL-1 inhibitor isunakinra to be added to already approved immunotherapy (PD-1/PD-L1 inhibitor) in an attempt to get this treatment to work in this treatment resistant type of tumor.

Interventions

  • DRUG isunakinra

Study Locations (2)

California

  • USC/Norris Cancer Center — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-01-30
Est. Completion 2026-12
Phase Phase 2

Sponsor

Buzzard Pharmaceuticals

29 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06634875

The ClinicalTrials.gov registry entry for NCT06634875 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Buzzard Pharmaceuticals, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention — of which isunakinra is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06634875 reports 2 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06634875 about?

NCT06634875 is a clinical study titled "Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)". This study will enroll patients with colorectal cancer that is locally advanced or metastatic. The tumor must be microsatellite stable (MSS), have a tumor mutational burden that is high (TMB-H) and be kras mutated. Patients must have been treated with available approved treatments already. In this s...

What is the current status of trial NCT06634875?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-01-30. Estimated completion is 2026-12.

What conditions does trial NCT06634875 study?

This clinical trial studies the following conditions: Colorectal Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06634875?

The interventions under investigation include: isunakinra (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06634875?

This trial is sponsored by Buzzard Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06634875 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial