Safety, PK, PD, and Clinical Activity of KT-413 in Adult with Relapsed or Refractory B-cell NHL

• Research type

  Research Study

• Full title

  A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-413 in Adult Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

• IRAS ID

  1006711

• Contact name

  Muhammad Khan

• Contact email

  mkhan@kymeratx.com

• Sponsor organisation

  Kymera Therapeutics, Inc

• Eudract number

  2022-003102-74

• Clinicaltrials.gov Identifier

  NCT05233033

• Research summary

  This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in patients with R/R NHL. The Phase 1a stage of the study will explore escalating doses of single-agent KT-413. The Phase 1b stage will be split into 2 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in MYD88 mutant and MYD88 wild-type R/R DLBCL.

  Lay summary of study results: N/A
  No patients screened in the UK.
  Sponsor decided to terminate this Phase 1 trial prior to its anticipated ending per protocol due to a strategic portfolio decision. At the time of study termination, patients were enrolled through dose level 4 (0.82 mg/kg).

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  22/WM/0263

• Date of REC Opinion

  30 Dec 2022

• REC opinion

  Further Information Favourable Opinion