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KT-413

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

KT-413 · 1 trial · 4 indications

Phase 1 1
NCT05233033Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients with Relapsed or Refractory B-cell NHLNon Hodgkin Lymphoma
COMPLETED7 Analytics
PHASE1COMPLETED
Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL
Non Hodgkin Lymphoma
NCT052330337
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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 to 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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Frequently asked questions about KT-413

What is KT-413 used for?

KT-413 is an investigational small molecule being developed for the treatment of Non Hodgkin Lymphoma, specifically relapsed or refractory B-cell NHL, including Diffuse Large B Cell Lymphoma (DLBCL) with MYD88 gene mutations. It is currently in Phase 1 clinical development.

Who is developing KT-413?

KT-413 is being developed by Kymera Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KYMR. The company is conducting clinical trials to evaluate the safety and efficacy of KT-413 in patients with certain types of lymphoma.

What phase is KT-413 in?

KT-413 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for its safety, pharmacokinetics, pharmacodynamics, and clinical activity.

What clinical trials is KT-413 in?

KT-413 has been studied in a Phase 1 clinical trial with the identifier NCT05233033. This trial evaluated the safety, pharmacokinetics, pharmacodynamics, and clinical activity of KT-413 in adult patients with relapsed or refractory B-cell NHL, including DLBCL with MYD88 mutations. The trial was conducted in the United States and the United Kingdom.

What is the mechanism of action of KT-413?

KT-413 is a small molecule therapeutic. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential to treat certain types of B-cell lymphoma, particularly those with MYD88 gene mutations.