A Phase 1b/2 dose-escalation study in B-Lymphoid Malignancies

• Research type

  Research Study

• Full title

  A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies

• IRAS ID

  245868

• Contact name

  Talha Munir

• Contact email

  tmunir@nhs.net

• Sponsor organisation

  Sunesis Pharmaceuticals, Inc.

• Eudract number

  2018-000108-41

• Clinicaltrials.gov Identifier

  NCT03037645

• Duration of Study in the UK

  4 years, 8 months, 28 days

• Research summary

  The purpose of the study is to test the investigational drug known as vecabrutinib (SNS-062), a Bruton’s tyrosine kinase (BTK) inhibitor, for safety, pharmacokinetics (how the body processes the drug)and antitumor activity in adults aged 18 years and over, who have advanced B-lymphoid malignancies that have become resistant and have progressed after prior treatments, in order to induce tumour regression or delay tumour progression.
  The study consists of two phases;
  • Phase 1b of the study is a Dose Escalation phase, which means that doses are tested and evaluated; increasing in
  strength to each group of patients over time. The purpose of Phase 1b is to identify a recommended dose to be
  studied further in Phase 2 based on safety and activity.
  • Phase 2 of the study is a Dose Expansion phase, which means this dose will be given to more patients with previously treated B-cell malignancies (Chronic lymphocytic leukemia/small lymphocytic lymphoma), the purpose of the Dose Expansion phase is to evaluate the effectiveness of the recommended dose of vecabrutinib.
  In Phase 1B is expected to last up to approximately 18 months, a small cohort (3 to 6) patients will be given a starting dose of, vecabrutinib., if this dose is tolerated with manageable side effects, the next cohort will be given a higher dose of vecabrutinib. The dose will be increased with each patient cohort until the highest tolerated or recommended dose is determined.
  Approximately 120 patients will take part in Phase 2 that is expected to last 36 months. The study will take place at 50 sites in France, Italy, Spain, United Kingdom and United States. United Kingdom will only participate in Phase 2 of the study.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0415

• Date of REC Opinion

  6 Feb 2019

• REC opinion

  Further Information Favourable Opinion