Phase
Condition
Neoplasms
Treatment
KZR-261
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system [CNS] neoplasms), defined as cancer that iseither metastatic or locally advanced and unresectable (and for which additionalradiation therapy or other locoregional therapies are not considered to result inreasonable clinical benefit).
Disease that is resistant to or relapsed following available standard systemictherapy, or for which there is no standard systemic therapy or reasonable therapy inthe Investigator's judgement likely to result in clinical benefit, or if suchtherapy has been refused by the subject. Documentation of the reason must beprovided for subjects who have not received a standard therapy likely to result inclinical 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, prostate cancer, mesothelioma).
Exclusion
Exclusion Criteria:
Subjects who have participated in Part 1 dose escalation are not eligible to enrollin 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 thesubject's first dose of KZR-261.
Radiation therapy within 14 days of before administration of the subject's firstdose of KZR-261.
Major surgical procedure within 28 days before administration of the subject's firstdose 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, orwho are actively trying to conceive at the time of signing of the informed consentform (ICF).
Uncontrolled, clinically significant pulmonary disease.
Study Design
Study Description
Connect with a study center
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University Hospitals - Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Sara Cannon Research Institution (SCRI) - Tennessee Oncology Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas 78229
United StatesSite Not Available
Virginia Cancer Specialists (VCS)
Fairfax, Virginia 22031
United StatesSite Not Available
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesSite Not Available
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