Phase I dose escalation study for VIP152 (BAY 1251152)

• Research type

  Research Study

• Full title

  An open-label, multicenter Phase I dose escalation study to characterize safety, tolerability, preliminary antitumor activity, pharmacokinetics and maximum tolerated dose of VIP152(BAY 1251152) in subjects with advanced cancer.

• IRAS ID

  306901

• Contact name

  Ahmed Hamdy

• Contact email

  ahmed.hamdy@vincerx.com

• Sponsor organisation

  Vincerx Pharma, Inc

• Eudract number

  2014-004808-30

• Clinicaltrials.gov Identifier

  NCT02635672

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  3 years, 11 months, 17 days

• Research summary

  This is an open-label, multicentre Phase I, dose escalation study of VIP152 in sequential and expansion cohorts of subjects with advanced tumours.
  This phase 1 study has two parts. Part 1 is the dose-escalation and Part 2 is the expansion cohorts.
  The dose escalation portion (Part 1) of the study has been completed and MTD is 30 mg.
  Part 2 of the study consists of open-label, parallel expansion cohorts in subjects with advanced tumors harboring MYC aberrations (eg, aggressive NHL and solid tumors, for example, ovarian cancer and TNBC) as confirmed by FoundationOne panel (or similar commercial panel) or local pathology results. Treatment (30 mg intravenous (IV)infusion) will be given once weekly in cycles of 21 days until evidence of progression, unacceptable toxicity, consent withdrawal, or withdrawal from the study at the discretion of the investigator. The purpose of the Part 2 expansion cohorts is to further explore the safety, anticancer activity and pharmacokinetics of VIP152 across histologies/subtypes with confirmed MYC overexpression/amplification/translocation.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  21/NW/0356

• Date of REC Opinion

  24 Jan 2022

• REC opinion

  Further Information Favourable Opinion