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NCT06634875 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Colorectal Cancer Metastatic, sponsored by Buzzard Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT06634875: Recruiting Phase 2 study of Colorectal Cancer Metastatic, sponsored by Buzzard Pharmaceuticals.

NCT06634875 is a Phase 2 study of Colorectal Cancer Metastatic that is actively recruiting participants, run by Buzzard Pharmaceuticals. The registered enrollment target is 20 participants, below the 204-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06634875, a Phase 2 study of Colorectal Cancer Metastatic, is actively recruiting participants, sponsored by Buzzard Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

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.

Primary Outcome

The incidence, relatedness and severity of adverse events (includes safety laboratory abnormalities) per CTCAE v. 5

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
Buzzard Pharmaceuticals

2 total trials

What NCT06634875 shows while recruiting

NCT06634875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 204-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (90% lower).

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.

NCT06634875 reports a single indexed study location in California.

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.

What interventions are being tested in trial NCT06634875?

The interventions under investigation include: isunakinra (DRUG).

Who is sponsoring clinical trial NCT06634875?

This trial is sponsored by Buzzard Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Colorectal Cancer Metastatic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06634875's enrollment target sits among peer trials

20 15th of 18 higher than 4 of 18 other Colorectal Cancer Metastatic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06634875, the US trial registry maintained by the National Library of Medicine. NCT06634875 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.