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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05225584
Other study ID # KT333-TL-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 19, 2022
Est. completion date March 2025

Study information

Verified date June 2023
Source Kymera Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Intervention

Drug:
KT-333
KT-333 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined frequency and dose level.

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Sponsors (1)

Lead Sponsor Collaborator
Kymera Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Incidence and severity of adverse events as assessed by CTCAE v5.0 Phase 1a/1b Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Primary Safety 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 Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Primary Safety 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 Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Primary Maximum Tolerated Dose (MTD) To establish the Maximum Tolerated Dose (MTD) Phase 1a Within the first 28 days of treatment
Primary Dose Limiting Toxicities (DLTs) Number of Participants with protocol specified Dose Limiting Toxicities (DLTs) Phase 1a Within the first 28days of treatment
Secondary Area under the plasma concentration versus time curve for KT-333 Area under the plasma concentration versus time curve for KT-333 from time to zero to last quantifiable time point (AUC 0-t ) Phase 1a/1b Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Secondary Maximum Plasma Concentration of KT-333 (Cmax) Maximum Plasma Concentration of KT-333 (Cmax) Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Secondary Time of maximum plasma concentration of KT-333 (Tmax) Time of maximum plasma concentration of KT-333 (Tmax) Phase 1a/1b Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Secondary Half-life of KT-333 if data permits (T1/2) Half-life of KT-333 if data permits (T1/2) Phase 1a/1b Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Secondary Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t) Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t) Phase 1a Urine samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Secondary Evidence of clinical activity of KT-333 Evidence of clinical activity of KT-333 as determined by Objective Response Rate (ORR) as per Lugano criteria 2014 for Lymphomas Phase 1a/1b. From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Secondary Evidence of clinical activity of KT-333 Evidence of clinical activity of KT-333 as determined by RECIST 1.1 to determine ORR , complete response (CR), partial response (PR) for solid tumors Phase 1a/1b. From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Secondary Evidence of clinical activity of KT-333 Evidence of clinical activity of KT-333 as determined by ORR by Modified Severity-Weighted Assessment Tool (mSWAT) for Cutaneous T-Cell Lymphoma (CTCL) Phase 1a/1b Composite assessment from date of baseline assessment until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Secondary Evidence of clinical activity of KT-333 Evidence of clinical activity of KT-333 as determined by ORR by investigator assessment for Large Granular Lymphocytic Leukemia (LGL-L) Phase 1a/1b From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Secondary Evidence of clinical activity of KT-333 Evidence of clinical activity of KT-333 as determined by ORR based on T-PLL International Study Group criteria, Phase 1a From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Secondary Duration of Response (DOR) Duration of Response (DOR) Phase 1a/1b From date of first of response to the date of documented first progression or death whichever comes first, about 18 months
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