Spots Global Cancer Trial Database for Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors
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Trial Identification
Brief Title: Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors
Official Title: 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
Study ID: NCT05225584
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
MD Anderson Cancer Center, Houston, Texas, United States
University of Virginia, Emily Couric Cancer Center, Charlottesville, Virginia, United States
University of WA/Seattle Cancer Care Alliance, Seattle, Washington, United States
Contact Details
Name: Ashwin Gollerkeri, MD
Affiliation: Kymera Therapeutics, Inc.
Role: STUDY_DIRECTOR
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