KB-0742-1001: FIH study of KB-0742 in solid tumours or NHL

• Research type

  Research Study

• Full title

  Phase 1, first-in-human, open-label dose escalation and cohort expansion study of KB-0742 in patients with relapsed or refractory solid tumors or non-Hodgkin lymphoma

• IRAS ID

  1004418

• Contact name

  Marc Besman

• Contact email

  regaffairs@kronosbio.com

• Sponsor organisation

  Kronos Bio Inc.

• Clinicaltrials.gov Identifier

  NCT04718675

• Research summary

  This study is a first-in-human study, which will be conducted in approximately 170 male and female participants with relapsed or refractory (R/R) solid tumours or non-Hodgkin lymphoma (NHL). This study consists of 2 parts. In Part 1 sequential groups of participants will receive escalating doses of the study medication KB-0742. In Part 2, following identification of the recommended dose and schedule of KB-0742 from Part 1 of the study, the following groups of participants will be enrolled:
  Cohort A: R/R solid tumours (incl. approximately 10 patients each with non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and ovarian cancer)
  Cohort B: R/R small cell lung cancer (SCLC) and soft tissue sarcomas with evidence of transcription factor dysregulation.
  Part 1 will be conducted in the USA only and Part 2 will be conducted worldwide.

  The study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase consisting of consecutive 28-day cycles and an End-of-Treatment Evaluation. During the Treatment Phase, participants will undergo study visits on Days 1, 4, 8, 10, 11, 15, and 22 in Cycle 1, Days 1, 8, 15 and 22 in Cycle 2, and Days 1 and 15 in Cycle 3 and beyond, for evaluation of KB-0742 safety, pharmacokinetics, pharmacodynamics, and efficacy. An End-of-study evaluation will take place 30 (± 7) days after permanent discontinuation of KB-0742 or prior to initiation of new anticancer therapy (whichever is sooner). Participants will receive KB-0742 until progression, intolerance or withdrawal from study by the participant or study investigator. During the course of the study, participants will undergo a number of different procedures including imaging, blood sampling, ECGs and physical examinations.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  23/EE/0180

• Date of REC Opinion

  30 Nov 2023

• REC opinion

  Further Information Favourable Opinion