M24-533 (AndroMETa-CRC-533)

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Subjects with Metastatic Colorectal Cancer (AndroMETa-CRC-533)

• IRAS ID

  1011725

• Contact name

  Bernhard Dodell

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Clinicaltrials.gov Identifier

  NCT06820463

• Research summary

  CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.

  Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC.

  This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will
  then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab.

  Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.

  In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage
  participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  25/LO/0393

• Date of REC Opinion

  1 Sep 2025

• REC opinion

  Further Information Favourable Opinion