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Taking people in United KingdomPhase 2

Tests telisotuzumab adizutecan with chemotherapy in metastatic colorectal cancer

Tests telisotuzumab adizutecan with standard drugs in adults with metastatic colorectal cancer.

Key facts

Who runs it
AbbVie
Where
Birmingham, London, Manchester, Oxford, and Sutton, United KingdomSee the 5 sitesAlso in 14 other countries, 85 sites
Registry title
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 2
People taking part
390 people, planned
Started
24 Apr 2025
Expected to end
Apr 2028
Type of study
Interventional, 8 groups
Treatments tested
  • Telisotuzumab Adizutecan
  • Fluorouracil
  • Oxaliplatin
  • Leucovorin
  • Bevacizumab
  • Panitumumab
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with metastatic colorectal cancer who have measurable disease and are well enough to be up and about (ECOG 0 or 1).

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Metastatic colorectal cancer with measurable disease per RECIST v1.1.
Earlier treatment
People cannot have had a c-Met targeting drug (such as an antibody, antibody drug conjugate or bispecific) or any topoisomerase inhibitor (such as irinotecan).

Main reasons for not taking part

  • Earlier treatment with a c-Met targeting drug
  • Earlier treatment with a topoisomerase inhibitor, such as irinotecan
  • Another cancer within the past 5 years, unless it has a negligible risk of spreading or causing death

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Laboratory values meeting the criteria within the protocol
  • Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1

Who cannot take part

  • Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan)
  • History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes how well you can look after yourself and be active?

Where in United Kingdom

Also in 14 other countries, 85 sites

  • Heartlands Hospital - University Hospitals Birmingham /ID# 271178Birmingham, United KingdomTaking people
  • Barts Health NHS Trust /ID# 271189London, United KingdomTaking people
  • The Christie NHS Foundation Trust - Christie Hospital /ID# 271561Manchester, United KingdomTaking people
  • Oxford University Hospitals Nhs Foundation Trust /ID# 272486Oxford, United KingdomTaking people
  • The Royal Marsden - Sutton /ID# 271172Sutton, United KingdomTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

The 8 groups in the trial

  • Substudy 1: Dose Escalation Telisotuzumab AdizutecanTreatment being tested

    Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration.

    Treatment: Telisotuzumab Adizutecan, Fluorouracil, Oxaliplatin, Leucovorin, and Bevacizumab

  • Substudy 1: Dose Expansion Telisotuzumab Adizutecan High DoseTreatment being tested

    Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

    Treatment: Telisotuzumab Adizutecan, Fluorouracil, Oxaliplatin, Leucovorin, and Bevacizumab

  • Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low DoseTreatment being tested

    Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

    Treatment: Telisotuzumab Adizutecan, Fluorouracil, Oxaliplatin, Leucovorin, and Bevacizumab

  • Substudy 1: Dose Expansion CompatatorTreatment being tested

    Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

    Treatment: Fluorouracil, Oxaliplatin, Leucovorin, and Bevacizumab

  • Substudy 2: Dose Escalation Telisotuzumab AdizutecanTreatment being tested

    Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration.

    Treatment: Telisotuzumab Adizutecan, Fluorouracil, Leucovorin, and Panitumumab

  • Substudy 2: Dose Expansion Telisotuzumab Adizutecan High DoseTreatment being tested

    Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

    Treatment: Telisotuzumab Adizutecan, Fluorouracil, Leucovorin, and Panitumumab

  • Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low DoseTreatment being tested

    Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

    Treatment: Telisotuzumab Adizutecan, Fluorouracil, Leucovorin, and Panitumumab

  • Substudy 2: Dose Expansion CompatatorTreatment being tested

    Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.

    Treatment: Fluorouracil, Oxaliplatin, Leucovorin, and Panitumumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests telisotuzumab adizutecan with chemotherapy in metastatic colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06820463, who can take part
Record updated
27 October 2026