WP43295: Ph1A/B study of RO7276389 in participants with solid tumours

• Research type

  Research Study

• Full title

  A PHASE IA/B OPEN-LABEL STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7276389 ALONE AND IN COMBINATION WITH COBIMETINIB IN PARTICIPANTS WITH BRAF-V600 MUTATION-POSITIVE ADVANCED SOLID TUMOR OR BRAF-V600 MUTATION-POSITIVE MELANOMA WITH CENTRAL NERVOUS SYSTEM METASTASES

• IRAS ID

  1004294

• Contact name

  Kirsty Brown

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F.Hoffmann-La Roche Ltd

• Eudract number

  2021-003426-77

• ISRCTN Number

  ISRCTN13713551

• Research summary

  The BRAF mutation has been observed in approximately 8% of all solid tumours. BRAF-targeted treatments have shown promise in the treatment of advanced melanoma, including in patients with brain metastases, however, with limited treatment benefit, highlighting the need for improved drugs that target this mutation. Brain metastases represent a significant therapeutic challenge and are particularly common in advanced melanoma.
  RO7276389 is a novel BRAF inhibitor intended to target tumours with BRAF-V600 mutation with enhanced brain penetration properties and therefore may add clinical benefit to either treatment naïve or experienced patients with BRAF mutations.
  This is a 2 part, Global Phase 1 open label study of RO7276389 in patients with BRAF-V600 mutation positive advanced solid tumours or melanoma with brain metastases.
  • Part A Dose Escalation: will assess the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (“RP2D”) for RO7276389 alone and in combination with cobimetinib in patients with BRAF-V600 mutation positive solid tumours. Approximately 120 patients will be enrolled globally.
  • Part B Dose Expansion: will evaluate preliminary anti-tumour activity of the RP2D dose in patients with melanoma with brain metastases and investigate safety, tolerability and pharmacokinetics. Approximately 160 patients will be enrolled globally.
  All patients will receive treatment with RO7276389 alone or in combination with cobimetinib up to a maximum of 24 months.
  3 UK sites will participate in this study sponsored by F. Hoffmann-La Roche.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  22/NW/0007

• Date of REC Opinion

  9 Mar 2022

• REC opinion

  Further Information Favourable Opinion