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Experimental cancer drug KZR-261 tested in early trial

NCT ID NCT05047536

Disease control Sponsor: Kezar Life Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called KZR-261 in 61 people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety, find the right dose, and see if the drug could shrink tumors. The trial was terminated, but the data collected helps understand how the drug works in the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KZR-261
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
What could go wrong
This was an early, small Phase 1 trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

61 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system \[CNS\] neoplasms), defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered to result in reasonable clinical benefit). * Disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the Investigator's judgement likely to result in clinical benefit, or if such therapy has been refused by the subject. Documentation of the reason must be provided for subjects who have not received a standard therapy likely to result in clinical benefit. * Eastern Cooperative Oncology Group Performance Status score of 0 or 1. * Adequate baseline hematologic and organ function. * Willing to use contraception. Additional Inclusion for Part 2: Histologic or cytologic evidence of malignancy (melanoma/uveal melanoma, colorectal cancer, castration-resistant prostate cancer, mesothelioma). Exclusion Criteria: * Subjects who have participated in Part 1 dose escalation are not eligible to enroll in Part 2 dose expansion. * Persistent clinically significant toxicities from previous anticancer therapy (excluding alopecia). * Treatment with cytotoxic, biologic, or targeted therapies for advanced cancer within 14 days before administration of the subject's first dose of KZR-261. * Treatment with an investigational drug within 28 days before administration of the subject's first dose of KZR-261. * Radiation therapy within 14 days of before administration of the subject's first dose of KZR-261. * Major surgical procedure within 28 days before administration of the subject's first dose of KZR-261. * History of risk factors for Torsades de pointes. * Active, symptomatic CNS metastases or primary CNS malignancy. * Any female who is breastfeeding or who plans to become pregnant during the study, or who are actively trying to conceive at the time of signing of the informed consent form (ICF). * Uncontrolled, clinically significant pulmonary disease.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma colorectal cancer colorectal neoplasm melanoma mesothelioma metastatic malignant neoplasm neoplasm Neoplasm Metastasis uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced / metastatic solid tumor

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • START (South Texas Accelerated Research Therapeutics)

    San Antonio, Texas, 78229, United States

  • Sara Cannon Research Institution (SCRI) - Tennessee Oncology Nashville

    Nashville, Tennessee, 37203, United States

  • University Hospitals - Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • Virginia Cancer Specialists (VCS)

    Fairfax, Virginia, 22031, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.