Metastatic Colorectal CancerPhase 2AndroMETa-CRCNCT06820463
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
A Phase 2 study testing Telisotuzumab Adizutecan, Fluorouracil and Oxaliplatin in people with Metastatic Colorectal Cancer, run by AbbVie at 81 sites in 15 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Telisotuzumab Adizutecan, Fluorouracil and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 81 sitesin 15 countries
- Study dates
- 24 Apr 2025to Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
81 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
81 sites in 15 countries
United States17 sites, 17 recruiting
- Recruiting
University Of Michigan /ID# 270790
Ann Arbor, Michigan, 48109-5000
- Recruiting
Texas Oncology - Austin Midtown /ID# 271354
Austin, Texas, 78705
- Recruiting
Dana-Farber Cancer Institute /ID# 270624
Boston, Massachusetts, 02215
- Recruiting
University of North Carolina at Chapel Hill /ID# 267786
Chapel Hill, North Carolina, 27514
- Recruiting
University of Chicago Medical Center /ID# 271688
Chicago, Illinois, 60637
- Recruiting
Oncology Hematology Care - Eastgate /ID# 271493
Cincinnati, Ohio, 45245
- Recruiting
City of Hope National Medical Center /ID# 270255
Duarte, California, 91010
- Recruiting
Virginia Cancer Specialists - Fairfax /ID# 271351
Fairfax, Virginia, 22031
- Recruiting
Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois, 60521
- Recruiting
Saint Lukes Hospital of Kansas City /ID# 270633
Kansas City, Missouri, 64111
- Recruiting
Northwest Georgia Oncology Centers /ID# 270245
Marietta, Georgia, 30060
- Recruiting
Yale New Haven Hospital /ID# 270565
New Haven, Connecticut, 06510
- Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska, 68130
- Recruiting
AdventHealth Orlando /ID# 270789
Orlando, Florida, 32803
- Recruiting
UCLA - Santa Monica /ID# 270621
Santa Monica, California, 90404
- Recruiting
University Of Washington /ID# 271298
Seattle, Washington, 98109
- Recruiting
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Webster, Texas, 77598
Brazil6 sites, 6 recruiting
- Recruiting
Hospital De Amor /ID# 271874
Barretos, São Paulo, 14784-400
- Recruiting
Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147
Ijuí, Rio Grande do Sul, 98700-000
- Recruiting
Hospital Sao Rafael /ID# 271681
Salvador, Estado de Bahia, 41253-190
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651
São José do Rio Preto, São Paulo, 15090-000
- Recruiting
Instituto D Or De Pesquisa E Ensino - Regional Sao Paulo /ID# 270546
São Paulo, 01401-002
- Recruiting
Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311
São Paulo, 04014-002
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Vall de Hebron /ID# 270191
Barcelona, 08035
- Recruiting
Clinica Universidad de Navarra - Madrid /ID# 269754
Madrid, 28027
- Recruiting
Hospital Universitario La Paz /ID# 269730
Madrid, 28046
- Recruiting
Clinica Universidad de Navarra - Pamplona /ID# 269753
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Marques de Valdecilla /ID# 269732
Santander, Cantabria, 39008
- Recruiting
Hospital Clinico Universitario de Valencia /ID# 269805
Valencia, 46010
Taiwan6 sites, 6 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724
Kaohsiung City, 807
- Recruiting
Kaohsiung Chang Gung Memorial Hospital /ID# 269726
Kaohsiung City, 833
- Recruiting
National Cheng Kung University Hospital /ID# 270835
Tainan, 704
- Recruiting
National Taiwan University Hospital /ID# 269717
Taipei, 100
- Recruiting
Taipei Veterans General Hospital /ID# 269718
Taipei, 112
- Recruiting
Linkou Chang Gung Memorial Hospital /ID# 269725
Taoyuan City, 333
Australia5 sites, 5 recruiting
- Recruiting
Austin Health /ID# 270692
Heidelberg, Victoria, 3084
- Recruiting
One Clinical Research /ID# 270695
Nedlands, Western Australia, 6009
- Recruiting
Mater Misericordiae /ID# 270694
South Brisbane, Queensland, 4101
Site Coordinator, +61731632341
- Recruiting
Macquarie University /ID# 271514
Sydney, New South Wales, 2109
- Recruiting
The Queen Elizabeth Hospital /ID# 270693
Woodville South, South Australia, 5011
Canada5 sites, 5 recruiting
- Recruiting
Arthur J.E Child Comprehensive Cancer Centre /ID# 269809
Calgary, Alberta, T2N 5G2
- Recruiting
Cross Cancer Institute. /ID# 272711
Edmonton, Alberta, T6G 1Z2
- Recruiting
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270680
London, Ontario, N6A 5W9
- Recruiting
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 271368
Montreal, Quebec, H1T 2M4
- Recruiting
Princess Margaret Cancer Centre /ID# 268715
Toronto, Ontario, M5G 2M9
Czechia5 sites, 5 recruiting
- Recruiting
Masarykuv onkologicky ustav v Brne /ID# 268779
Brno, 656 53
- Recruiting
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773
Hradec Králové, 500 05
- Recruiting
Vseobecna Fakultni nemocnice v Praze /ID# 268775
Prague, Praha 17, 128 00
- Recruiting
Fakultni nemocnice Motol a Homolka /ID# 268776
Prague, Praha 5, 150 06
- Recruiting
Fakultni Thomayerova nemocnice /ID# 269632
Prague, Praha, Hlavni Mesto, 140 59
France5 sites, 5 recruiting
- Recruiting
Chu De Lille - Hopital Claude Huriez /ID# 270222
Lille, Hauts-de-France, 59037
- Recruiting
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 270221
Nantes, Pays de la Loire Region, 44000
- Recruiting
Hopital Europeen Georges Pompidou /ID# 270224
Paris, 75015
- Recruiting
Hopital Pitie Salpetriere /ID# 270220
Paris, Île-de-France Region, 75013
- Recruiting
Centre Hospitalier Universitaire de Poitiers /ID# 270225
Poitiers, New Aquitaine, 86021
Greece5 sites, 5 recruiting
- Recruiting
University General Hospital Attikon /ID# 268555
Chaïdári, Attica, 12462
- Recruiting
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 268762
Nea Kifissia, Attica, 14564
- Recruiting
St. Luke's Hospital /ID# 269963
Panórama, Thessaloniki, 55236
- Recruiting
Metropolitan Hospital /ID# 269636
Piraeus, Attica, 18547
- Recruiting
Theagenio Cancer Hospital /ID# 269640
Thessaloniki, 54639
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus- Haifa /ID# 268006
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center /ID# 268009
Jerusalem, 9103102
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 268007
Jerusalem, 91120
- Recruiting
Rabin Medical Center. /ID# 268008
Petah Tikva, Central District, 4941492
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 268010
Tel Aviv, Tel Aviv, 6423906
Japan5 sites, 5 recruiting
- Recruiting
National Cancer Center Hospital /ID# 270112
Chuo-Ku, Tokyo, 104-0045
- Recruiting
National Cancer Center Hospital East /ID# 270114
Kashiwa-shi, Chiba, 277-8577
- Recruiting
St Marianna University School Of Medicine /ID# 270111
Kawasaki-shi, Kanagawa, 216-8511
- Recruiting
Aichi Cancer Center /ID# 270113
Nagoya, Aichi-ken, 464-8681
- Recruiting
Tohoku University Hospital /ID# 270966
Sendai, Miyagi, 980-8574
United Kingdom4 sites, 4 recruiting
- Recruiting
Barts Health NHS Trust /ID# 271189
London, Greater London, E1 2ES
- Recruiting
The Christie NHS Foundation Trust - Christie Hospital /ID# 271561
Manchester, M20 4BX
- Recruiting
Oxford University Hospitals Nhs Foundation Trust /ID# 272486
Oxford, Oxfordshire, OX3 9DU
- Recruiting
The Royal Marsden - Sutton /ID# 271172
Sutton, Surrey, SM2 5PT
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universitaet Graz /ID# 268876
Graz, Styria, 8010
- Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 268874
Salzburg, 5020
- Recruiting
Medizinische Universitaet Wien /ID# 268872
Vienna, 1090
Italy2 sites, 2 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda /ID# 269142
Milan, Milano, 20162
Site Coordinator, ctu.oncologia@ospedaleniguarda.it
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 269191
Naples, Napoli, 80138
Puerto Rico2 sites, 2 recruiting
- Recruiting
Pan American Center for Oncology Trials - Rio Piedras /ID# 268809
Rio Piedras, 00935
- Recruiting
Puerto Rico Medical Research Center /ID# 268825
San Juan, 00917-5022
About this study
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
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.
Read more
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Telisotuzumab Adizutecan, Fluorouracil, Oxaliplatin, Leucovorin, Bevacizumab
- Keywords
- Metastatic Colorectal Cancer, AndroMETa-CRC-533, Telisotuzumab Adizutecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Intravenous (IV) Infusion
FluorouracilDrug
IV Infusion; IV Injection
OxaliplatinDrug
IV Infusion
LeucovorinDrug
IV Infusion; IV Injection
BevacizumabDrug
IV Infusion
PanitumumabDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: Dose Escalation Telisotuzumab Adizutecan | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Bevacizumab |
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Bevacizumab |
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Bevacizumab |
| Substudy 1: Dose Expansion Compatator | Experimental | Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. Receives: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Bevacizumab |
| Substudy 2: Dose Escalation Telisotuzumab Adizutecan | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Fluorouracil; Drug: Leucovorin; Drug: Panitumumab |
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Fluorouracil; Drug: Leucovorin; Drug: Panitumumab |
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Fluorouracil; Drug: Leucovorin; Drug: Panitumumab |
| Substudy 2: Dose Expansion Compatator | Experimental | Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration. Receives: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
Measured: Up to 24 Weeks
Number of Participants with Adverse Events (AE)s
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.
Measured: Up to Approximately 6 Years
Secondary outcomes (4)
Progression-Free Survival (PFS) as Assessed by the Investigator
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.
Measured: Up to 22 Months
Duration of Response (DOR) as Assessed by the investigator
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.
Measured: Up to 14 Months
Overall Survival (OS)
OS is defined as the time from first dose of study treatment to the event of death from any cause.
Measured: Up to Approximately 6 Years
Disease Control (DC) as Assessed by the Investigator
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.
Measured: Up to Approximately 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start24 Apr 2025
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820463
- Sponsor's protocol ID
- M24-533
- Other IDs
- EU CT, 2024-512981-33-00
- Acronym
- AndroMETa-CRC
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.