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
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
3 other identifiers
interventional
390
11 countries
39
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Typical duration for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
April 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 15, 2026
April 1, 2026
2.9 years
February 6, 2025
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to Approximately 6 Years
Secondary Outcomes (4)
Progression-Free Survival (PFS) as Assessed by the Investigator
Up to 22 Months
Duration of Response (DOR) as Assessed by the investigator
Up to 14 Months
Overall Survival (OS)
Up to Approximately 6 Years
Disease Control (DC) as Assessed by the Investigator
Up to Approximately 6 Years
Study Arms (8)
Substudy 1: Dose Escalation Telisotuzumab Adizutecan
EXPERIMENTALParticipants 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.
Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose
EXPERIMENTALParticipants 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.
Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose
EXPERIMENTALParticipants 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.
Substudy 1: Dose Expansion Compatator
EXPERIMENTALParticipants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.
Substudy 2: Dose Escalation Telisotuzumab Adizutecan
EXPERIMENTALParticipants 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.
Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose
EXPERIMENTALParticipants 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.
Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose
EXPERIMENTALParticipants 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.
Substudy 2: Dose Expansion Compatator
EXPERIMENTALParticipants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.
Interventions
IV Infusion; IV Injection
Intravenous (IV) Infusion
IV Infusion
IV Infusion; IV Injection
IV Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (44)
City of Hope National Medical Center /ID# 270255
Duarte, California, 91010, United States
Yale New Haven Hospital /ID# 270565
New Haven, Connecticut, 06510, United States
Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois, 60521, United States
Dana-Farber Cancer Institute /ID# 270624
Boston, Massachusetts, 02215, United States
Saint Lukes Hospital of Kansas City /ID# 270633
Kansas City, Missouri, 64111, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska, 68130, United States
University of North Carolina Medical Center /ID# 267786
Chapel Hill, North Carolina, 27514, United States
Oncology Hematology Care - Eastgate /ID# 271493
Cincinnati, Ohio, 45245, United States
Texas Oncology - Austin Midtown /ID# 271354
Austin, Texas, 78705, United States
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Webster, Texas, 77598, United States
Macquarie University /ID# 271514
Sydney, New South Wales, 2109, Australia
Mater Hospital Brisbane /ID# 270694
South Brisbane, Queensland, 4101, Australia
The Queen Elizabeth Hospital /ID# 270693
Woodville, South Australia, 5011, Australia
Austin Health /ID# 270692
Heidelberg, Victoria, 3084, Australia
One Clinical Research /ID# 270695
Nedlands, Western Australia, 6009, Australia
Medizinische Universitaet Wien /ID# 268872
Vienna, 1090, Austria
ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 270147
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651
São José do Rio Preto, São Paulo, 15090-000, Brazil
Fakultní nemocnice Hradec Králové - Sokolská /ID# 268773
Hradec Králové, Hradec Kralove, 500 05, Czechia
Fakultni Thomayerova nemocnice /ID# 269632
Prague, Praha, Hlavni Mesto, 140 59, Czechia
Chu De Lille - Hopital Claude Huriez /ID# 270222
Lille, Hauts-de-France, 59037, France
Centre Hospitalier Universitaire de Poitiers /ID# 270225
Poitiers, Nouvelle-Aquitaine, 86021, France
Hôpital Européen Georges Pompidou /ID# 270224
Paris, 75015, France
St. Luke's Hospital S.A. /ID# 269963
Panórama, Thessaloniki, 55236, Greece
Theagenio Cancer Hospital /ID# 269640
Thessaloniki, 54639, Greece
Tel Aviv Sourasky Medical Center /ID# 268010
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 268006
Haifa, 3525408, Israel
Shaare Zedek Medical Center /ID# 268009
Jerusalem, 9103102, Israel
Hadassah Medical Center-Hebrew University /ID# 268007
Jerusalem, 91120, Israel
Rabin Medical Center. /ID# 268008
Petah Tikva, 4941492, Israel
Aichi Cancer Center /ID# 270113
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East /ID# 270114
Kashiwa-shi, Chiba, 277-8577, Japan
St Marianna University School Of Medicine /ID# 270111
Kawasaki-shi, Kanagawa, 216-8511, Japan
Tohoku University Hospital /ID# 270966
Sendai, Miyagi, 980-8574, Japan
National Cancer Center Hospital /ID# 270112
Chuo-Ku, Tokyo, 104-0045, Japan
Pan American Center for Oncology Trials /ID# 268809
Rio Piedras, 00935, Puerto Rico
Hospital Universitario Marques de Valdecilla /ID# 269732
Santander, Cantabria, 39008, Spain
Hospital Universitario Vall de Hebron /ID# 270191
Barcelona, 08035, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 269726
Kaohsiung City, Kaohsiung, 833, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724
Kaohsiung City, 807, Taiwan
National Cheng Kung University Hospital /ID# 270835
Tainan, 704, Taiwan
National Taiwan University Hospital /ID# 269717
Taipei, 100, Taiwan
Taipei Veterans General Hospital /ID# 269718
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 269725
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 11, 2025
Study Start
April 24, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.