Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KT-413 · 1 trial · 4 indications
Phase 1a
Phase 1a
Phase 1a/1b
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)
Incidence and severity of adverse events as assessed by CTCAE v5.0 (Phase 1a/1b)
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
| Arm | Type | Description |
|---|---|---|
| Phase 1a Dose Escalation | EXPERIMENTAL | - |
| Phase 1b Dose Expansion MYD88MT | EXPERIMENTAL | KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 mutant DLBCL. |
| Phase 1b Dose Expansion MYD88WT | EXPERIMENTAL | KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 wild type DLBCL. |
| Name | Type | Description |
|---|---|---|
| KT-413 | DRUG | KT-413 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined dose level. |
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...
KT-413 is an investigational small molecule developed by Kymera Therapeutics for the treatment of non-Hodgkin lymphoma, including relapsed or refractory B-cell lymphoma and diffuse large B-cell lymphoma (DLBCL). It is a targeted therapy being studied in adult patients whose disease has returned or not responded to prior treatment.
KT-413 is an IRAKIMiD, a small molecule designed to target IRAK4 and the IMiD substrate proteins Ikaros and Aiolos. This dual mechanism is intended to degrade these proteins and disrupt signaling pathways that support B-cell lymphoma growth, particularly in tumors with MYD88 gene mutations.
KT-413 is developed by Kymera Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker KYMR. Kymera is focused on targeted protein degradation therapies and is the sponsor of the clinical program evaluating KT-413 in B-cell non-Hodgkin lymphoma.
KT-413 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial evaluating KT-413 in relapsed or refractory B-cell non-Hodgkin lymphoma has been completed, with a total enrollment of 7 patients.
KT-413 has been evaluated in one Phase 1 clinical trial, NCT05233033, titled Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL. The trial enrolled 7 adults across the United States and United Kingdom and studied non-Hodgkin lymphoma, DLBCL, and MYD88 gene mutation. It is now completed.
KT-413 is being studied for relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL) and cases with MYD88 gene mutations. It is an investigational therapy in Phase 1 testing and is not approved for any indication.