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 (AndroMETa-CRC)

June 10, 2026 updated by: AbbVie

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

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University /ID# 271514
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Hospital Brisbane /ID# 270694
        • Contact:
          • Site Coordinator
          • Phone Number: +61731632341
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Recruiting
        • The Queen Elizabeth Hospital /ID# 270693
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health /ID# 270692
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research /ID# 270695
  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universitaet Wien /ID# 268872
  • Brazil
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311
      • São Paulo, Brazil, 01401-002
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 270546
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Recruiting
        • Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Hospital De Amor /ID# 271874
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773
    • Praha, Hlavni Mesto
      • Prague, Praha, Hlavni Mesto, Czechia, 140 59
        • Recruiting
        • Fakultni Thomayerova nemocnice /ID# 269632
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou /ID# 270224
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Recruiting
        • Chu De Lille - Hopital Claude Huriez /ID# 270222
    • New Aquitaine
      • Poitiers, New Aquitaine, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers /ID# 270225
  • Greece
      • Thessaloniki, Greece, 54639
        • Recruiting
        • Theagenio Cancer Hospital /ID# 269640
    • Thessaloniki
      • Panórama, Thessaloniki, Greece, 55236
        • Recruiting
        • St. Luke's Hospital /ID# 269963
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus- Haifa /ID# 268006
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center /ID# 268009
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 268007
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Recruiting
        • Rabin Medical Center. /ID# 268008
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 268010
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center /ID# 270113
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 270114
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Recruiting
        • St Marianna University School Of Medicine /ID# 270111
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital /ID# 270966
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital /ID# 270112
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials - Rio Piedras /ID# 268809
      • San Juan, Puerto Rico, 00917-5022
        • Recruiting
        • Puerto Rico Medical Research Center /ID# 268825
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall de Hebron /ID# 270191
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla /ID# 269732
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital /ID# 269726
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital /ID# 270835
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital /ID# 269718
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital /ID# 269717
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital /ID# 269725
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center /ID# 270255
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA - Santa Monica /ID# 270621
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital /ID# 270565
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center /ID# 271688
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope And Healing Cancer Services /ID# 271562
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute /ID# 270624
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Lukes Hospital of Kansas City /ID# 270633
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center /ID# 267786
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Oncology Hematology Care - Eastgate /ID# 271493
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Austin Midtown /ID# 271354
      • Webster, Texas, United States, 77598
        • Recruiting
        • Texas Oncology - Deke Slayton Cancer Center /ID# 271355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Substudy 1: Dose Escalation Telisotuzumab Adizutecan
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.
Drug: Bevacizumab
IV Infusion
Drug: Oxaliplatin
IV Infusion
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Experimental: Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose
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.
Drug: Bevacizumab
IV Infusion
Drug: Oxaliplatin
IV Infusion
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Experimental: Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose
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.
Drug: Bevacizumab
IV Infusion
Drug: Oxaliplatin
IV Infusion
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Experimental: Substudy 1: Dose Expansion Compatator
Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.
Drug: Bevacizumab
IV Infusion
Drug: Oxaliplatin
IV Infusion
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Experimental: Substudy 2: Dose Escalation Telisotuzumab Adizutecan
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.
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Drug: Panitumumab
IV Infusion
Experimental: Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose
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.
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Drug: Panitumumab
IV Infusion
Experimental: Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose
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.
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Drug: Panitumumab
IV Infusion
Experimental: Substudy 2: Dose Expansion Compatator
Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.
Drug: Oxaliplatin
IV Infusion
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Drug: Panitumumab
IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.
Time Frame: Up to 24 Weeks
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
Up to 24 Weeks
Number of Participants with Adverse Events (AE)s
Time Frame: Up to Approximately 6 Years
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 6 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by the Investigator
Time Frame: Up to 22 Months
PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
Up to 22 Months
Duration of Response (DOR) as Assessed by the investigator
Time Frame: Up to 14 Months
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first.
Up to 14 Months
Overall Survival (OS)
Time Frame: Up to Approximately 6 Years
OS is defined as the time from first dose of study treatment to the event of death from any cause.
Up to Approximately 6 Years
Disease Control (DC) as Assessed by the Investigator
Time Frame: Up to Approximately 6 Years
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.
Up to Approximately 6 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-533
  • EU CT (Other Identifier: 2024-512981-33-00)
  • 2024-512981-33-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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