A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, PK/PD, and Clinical Activity of Intravenously Administered KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL
Sponsor study identifier
interventional
7
2 countries
8
Study Start
June 13, 2022
Actual (reported)Primary Completion
July 28, 2023
Actual (reported)Study Completion
July 28, 2023
Actual (reported)This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in patients with R/R NHL. The Phase 1a stage of the study will explore escalating doses of single-agent KT-413. The Phase 1b stage will be split into 2 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in MYD88 mutant and MYD88 wild-type R/R DLBCL.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 28, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2022
Actual (reported)February 10, 2022
Actual (reported)June 13, 2022
Actual (reported)July 28, 2023
Actual (reported)July 28, 2023
Actual (reported)To establish the Maximum Tolerated Dose (MTD)
Phase 1a
Within first 3 weeks of treatment
Number of Participants with protocol specified Dose Limiting Toxicities (DLTs)
Phase 1a
Within first 3 weeks of treatment
Dose recommended for future studies
Phase 1a/1b
Within first 3 weeks of treatment
Clinical Laboratory Abnormalities
Incidence and severity of clinical laboratory abnormalities in serum chemistry, hematology, coagulation parameters, and urinalysis tests as assessed by CTCAE v5.0 (Phase 1a/1b)
Clinical laboratory abnormalities will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Area under the plasma concentration versus time curve for KT-413 from time zero to last quantifiable time point (AUC0-t)
Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Maximum Plasma Concentration of KT-413 (Cmax)
Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Time of maximum plasma concentration of KT-413 (Tmax)
Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Half-life of KT-413 [if data permits (T1/2)]
Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Amount of KT-413 excreted in urine from time zero to last collected timepoint (Ae0-t)
Urine samples for PK analysis collected during the first cycle (21 day cycle)
KT-413 levels in peripheral blood mononuclear cells
Blood samples for PD analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 mutant DLBCL.
KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 wild type DLBCL.
KT-413 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined dose level.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, United States
University College London Hospitals
Ashwin Gollerkeri, MD
Kymera Therapeutics, Inc.
7 participants (actual enrollment reported by the registry).
First Submitted
January 18, 2022
First Posted
February 10, 2022
Study Start
June 13, 2022
Actual (reported)Adverse Event Parameters
Incidence and severity of adverse events as assessed by CTCAE v5.0 (Phase 1a/1b)
Adverse Event Parameters will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
ECG Parameters
Changes in the ECG parameters, including heart rate and measures PR, QRS, QT, and QTc intervals as assessed by CTCAE v5.0 Phase 1a/1b
ECG Parameters will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Contact the study team to confirm eligibility.
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Primary Completion
July 28, 2023
Actual (reported)Study Completion
July 28, 2023
Actual (reported)Last Updated
December 10, 2024
Record last verified: 2024-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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