KZR-261 in Subjects With Advanced Solid Malignancies

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Eye Cancer Melanoma Prostate Cancer Solid Tumor Unknown Primary	NCT ID:	NCT05047536
Trial Phases:	Phase I	Protocol IDs:	KZR-261-101 (primary) NCI-2022-01096
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Kezar Life Sciences, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05047536

Summary

A first-in-human, open-label, multicenter, Phase 1 study of KZR-261 designed to assess the
safety and tolerability, preliminary anti-tumor activity, and pharmacokinetics (PK) of
KZR-261, as well as identify the recommended Phase 2 dose (RP2D). The study comprises a Part
1 (Dose Escalation) and a Part 2 (Dose Expansion) in solid organ tumors (melanoma/uveal
melanoma, mesothelioma, colorectal cancer, prostate cancer, and "All-Tumors").

Objectives

The first-in-human, open-label, multicenter, Phase 1 study of KZR-261, Study KZR-261-101,
will be conducted in two parts (dose escalation and dose expansion) to evaluate the safety
and tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor
activity of KZR-261 in subjects with locally advanced or metastatic solid malignancies for
whom no therapeutics are available that can confer a reasonable likelihood of clinical
benefit. The 5 tumor cohorts in the dose expansion part include advanced malignant:

- melanoma/uveal melanoma

- mesothelioma

- colorectal cancer

- castrate-resistant prostate cancer

- "All-Tumors"

Part 1 (Dose Escalation) and Part 2 (Dose Expansion) comprise a 4-week Screening Period, a
Treatment Period lasting approximately 24 weeks, 4-6-week Safety Follow-up, and a 12-month
Long-Term Follow-up Period (after last dose of study treatment), for a total study duration
of approximately 20 months.

Treatment Sites in Georgia

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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