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A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-333 in Adult Patients With Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or Refractory (R/R) Lymphomas, Large Granular Lymphocytic Leukemia (LGL-L), T-cell prolymphocytic leukemia (T-PLL), and Solid Tumors. The Phase 1a stage of the study will explore escalating doses of single-agent KT-333. The Phase Ib stage will consist of 4 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), LGL-L, and solid tumors.
This is an open-label Phase 1a (dose escalation)/1b (dose expansion) first-in-human study of KT-333 in adult patients. Patients with relapsed/refractory (R/R) lymphomas, LGL-L, T-PLL, and solid tumors will be enrolled in Phase 1a. Phase 1b will consist of separate cohorts of patients with R/R PTCL, CTCL, LGL-L, and solid tumors.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hackensack University Medical Center, John Theurer Cancer Center
Hackensack, New Jersey, United States
Montefiore Medical Center, The University Hospital for Albert Einstein College of Medicine
The Bronx, New York, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Start Date
May 19, 2022
Primary Completion Date
March 3, 2025
Completion Date
March 3, 2025
Last Updated
March 19, 2025
56
ACTUAL participants
KT-333
DRUG
Lead Sponsor
Kymera Therapeutics, Inc.
NCT03199066
NCT04072458
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05329792