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KT-253

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05775406Safety and Clinical Activity of KT-253 in Adult Patients with High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid TumorsPHASE1 COMPLETED 52 — — May 15, 2023Dec 18, 2024Jan 27, 202511 United States
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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 — 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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