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KT-333

Phase 1

Non Hodgkin Lymphoma (NHL) | Small molecule | Oncology |Kymera Therapeutics, Inc.|Last Updated: Mar 19, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

FAST_TRACKORPHAN_DRUG

Clinical trial landscape

KT-333 · 1 trial · 6 indications

Phase 1 1
NCT05225584Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid TumorsNon Hodgkin Lymphoma (NHL)
COMPLETED56 Analytics
PHASE1COMPLETED
Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors
Non Hodgkin Lymphoma (NHL)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety
Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy

Incidence and severity of adverse events as assessed by CTCAE v5.0 Phase 1a/1b

Maximum Tolerated Dose (MTD)
Within the first 28 days of treatment

To establish the Maximum Tolerated Dose (MTD) Phase 1a

Dose Limiting Toxicities (DLTs)
Within the first 28days of treatment

Number of Participants with protocol specified Dose Limiting Toxicities (DLTs) Phase 1a

Secondary Endpoints

Area under the plasma concentration versus time curve for KT-333
Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
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)
Time of maximum plasma concentration of KT-333 (Tmax)
Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a Dose Escalation LymphomasEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1a Dose Escalation Solid TumorsEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1b Dose Expansion PTCLEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1b Dose Expansion CTCLEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1b Dose Expansion LGL-LEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1b Dose Expansion Solid TumorEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1a Dose Escalation LGL-LEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles
Phase 1a Dose Escalation T-PLLEXPERIMENTALKT-333 dosed IV weekly in 28 day cycles

Interventions

NameTypeDescription
KT-333DRUGKT-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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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Phase 1a Only: Cytologically or pathologically confirmed Lymphomas (including Hodgkin's, B-cell, T-cell, Small Lymphocytic, or Natural-Killer (NK)-cell Lymphomas and LGL-L), T-PLL and solid tumors with the exception of chronic lymphocytic leukemia (CLL) Note: Patients with in...

Countries:United States
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Frequently asked questions about KT-333

What is KT-333 used for in Non Hodgkin Lymphoma?

KT-333 is an investigational small molecule being studied for the treatment of Non Hodgkin Lymphoma (NHL). It is also being evaluated in other blood cancers and solid tumors, including Peripheral T-cell Lymphoma, Cutaneous T-Cell Lymphoma, Large Granular Lymphocytic Leukemia, T-cell Prolymphocytic Leukemia, and solid tumors.

Who makes KT-333?

KT-333 is being developed by Kymera Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KYMR. The company is conducting clinical research on this investigational small molecule for oncology indications.

What phase is KT-333 in?

KT-333 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track and Orphan Drug designations from the FDA for its studied indications.

What clinical trials is KT-333 in?

KT-333 has one completed Phase 1 clinical trial, registered as NCT05225584. This study evaluated the safety, pharmacokinetics, pharmacodynamics, and clinical activity of KT-333 in adult patients with refractory lymphoma, large granular lymphocytic leukemia, and solid tumors. The trial enrolled 56 participants in the United States.

What does KT-333 target?

KT-333 is a small molecule developed by Kymera Therapeutics. The specific molecular target of KT-333 has not been disclosed in the available clinical trial information. The drug is being studied for its potential activity in hematologic malignancies and solid tumors.