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KT-413

Phase 1

Non Hodgkin Lymphoma | Small molecule | Oncology |Kymera Therapeutics, Inc.|Last Updated: Dec 10, 2024

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 Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05233033Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients with Relapsed or Refractory B-cell NHLPHASE1 COMPLETED 7 — — Jun 13, 2022Jul 28, 2023Dec 10, 20248 United States, United Kingdom
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Study Endpoints
Primary Endpoints
To establish the Maximum Tolerated Dose (MTD)
Within first 3 weeks of treatment

Phase 1a

Number of Participants with protocol specified Dose Limiting Toxicities (DLTs)
Within first 3 weeks of treatment

Phase 1a

Dose recommended for future studies
Within first 3 weeks of treatment

Phase 1a/1b

Clinical Laboratory Abnormalities
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

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)

Adverse Event Parameters
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

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

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

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

Secondary Endpoints
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)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a Dose EscalationEXPERIMENTAL -
Phase 1b Dose Expansion MYD88MTEXPERIMENTALKT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 mutant DLBCL.
Phase 1b Dose Expansion MYD88WTEXPERIMENTALKT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 wild type DLBCL.
Interventions
NameTypeDescription
KT-413DRUGKT-413 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined dose level.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Phase 1a Only: * Histologically confirmed diagnosis of B-cell NHL according to the 2016 World Health Organization (WHO) classification. Diffuse large B-cell lymphoma (DLBCL) includes: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and/or BCL6 rearrangement...

Countries:United StatesUnited Kingdom
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