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KT-253

Phase 1

Myeloid Malignancies | Small molecule | Oncology |Kymera Therapeutics, Inc.|Last Updated: Jan 27, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

ORPHAN_DRUG

Clinical trial landscape

KT-253 · 1 trial · 4 indications

Phase 1 1
NCT05775406Safety and Clinical Activity of KT-253 in Adult Patients with High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid TumorsMyeloid Malignancies
COMPLETED52 Analytics
PHASE1COMPLETED
Safety and Clinical Activity of KT-253 in Adult Patients with High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid Tumors
Myeloid MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of adverse events
From the time of signing ICF through 30 days after last dose of study drug or prior to start of a new anticancer therapy

Adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) in Patients
From the time of the first dose of study drug through 30 days after the last dose of study drug or prior to start of a new anticancer therapy

MTD and RP2D will be determined in patients with R/R high grade myeloid malignancies, ALL, and separately, in patients with lymphomas and advanced solid tumors

Secondary Endpoints

Area under the Plasma Concentration versus Time Curve (AUC) of KT-253
Blood samples for PK analysis collected up to Day15 during cycle 1 and cycle 2 (each cycle is 21 days)
Maximum Plasma Concentration of KT-253 (Cmax)
Blood samples for PK analysis collected up to Day15 during cycle 1 and cycle 2 (each cycle is 21 days)
Time to maximum plasma concentration of KT-253 (Tmax)
Blood samples for PK analysis collected up to Day15 during cycle 1 and cycle 2 (each cycle is 21 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Dose Escalation Arm A in patients with R/R Solid Tumors and LymphomasEXPERIMENTALKT-253 dosed intravenous (IV) once every three weeks in 21-day cycles
Phase 1 Dose Escalation Arm B in patients with R/R High Grade Myeloid Malignancies and ALLEXPERIMENTALKT-253 dosed IV once every three weeks in 21-day cycles

Interventions

NameTypeDescription
KT-253DRUGKT-253 will be administered intravenously per the defined protocol frequency and dose level.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. All Participants: * Eastern Cooperative Oncology Group performance status: 0-2. * Resolved acute effects of any prior therapy except for alopecia to baseline severity or Grade ≤1 NCI CTCAE and Grade ≤2 neuropathy * Adequate organ function at screening 2. Solid Tumor...

Countries:United States
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Frequently asked questions about KT-253

What is KT-253 used for?

KT-253 is an investigational small molecule being studied for the treatment of myeloid malignancies, including high grade myeloid malignancies. It is also being evaluated in acute lymphocytic leukemia, lymphomas, and advanced solid tumors. The drug is in Phase 1 clinical development and has not been approved by the FDA.

Who makes KT-253?

KT-253 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-253 in?

KT-253 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received orphan drug designation from the FDA for its intended oncology indications.

What clinical trials is KT-253 in?

KT-253 has one completed Phase 1 clinical trial, identified as NCT05775406. This trial evaluated the safety and clinical activity of KT-253 in adult patients with high grade myeloid malignancies, acute lymphocytic leukemia, lymphoma, and advanced solid tumors. The trial enrolled 52 participants in the United States.

Is KT-253 the same as any other drug?

KT-253 is the primary name for this investigational drug developed by Kymera Therapeutics. No alternative names have been reported for this compound in the available clinical trial information.