A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer
- Summary
- Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 990 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months. 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.
- Acronym
- AndroMETa-CRC
- Short title
- A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer
- Official title
- An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2030-03-01
- First posted
- 2026-04-13
- Registry last updated
- 2026-10-19
- Primary completion date
- 2029-05-01
- Start date
- 2026-05-22
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07525206
- ClinicalTrials.gov ID
- NCT07525206
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
Timeframe: Up to Approximately 15 Months
Best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Phase 3: Overall Survival (OS)
Timeframe: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup >= 10%, 3+
Timeframe: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup < 10%, 3+
Timeframe: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)
Timeframe: Up to Approximately 24 Months
PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Phase 3: Duration Of Response (DoR) as assessed by BICR
Timeframe: Up to Approximately 24 Months
DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.
Phase 3: Disease Control (DC) as assessed by BICR:
Timeframe: Up to Approximately 24 Months
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
- Life expectancy >= 12 weeks per investigator assessment
- Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC.
- History of intolerance, allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. This also includes patients with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- City Of Hope - Phoenix /ID# 279450Goodyear, United StatesRecruiting
- Highlands Oncology Group - Springdale /ID# 279444Springdale, United StatesRecruiting
- City of Hope National Medical Center /ID# 279449Duarte, United StatesRecruiting
- Rocky Mountain Cancer Centers - Aurora /ID# 280112Aurora, United StatesRecruiting
- Yale University School of Medicine /ID# 279373New Haven, United StatesRecruiting
- Moffitt Cancer Center /ID# 279325Tampa, United StatesRecruiting
- City Of Hope - Atlanta /ID# 280017Newnan, United StatesRecruiting
- University of Chicago Medical Center /ID# 279365Chicago, United StatesRecruiting
- Saint Lukes Hospital of Kansas City /ID# 279513Kansas City, United StatesRecruiting
- Astera Cancer Care /ID# 279532East Brunswick, United StatesRecruiting
- Northwell Health Center for Advanced Medicine. /ID# 279590Lake Success, United StatesRecruiting
- Duke University Medical Center /ID# 279322Durham, United StatesRecruiting
- Oncology Hematology Care - Blue Ash /ID# 280143Cincinnati, United StatesRecruiting
- Compass Oncology - Rose Quarter /ID# 280127Portland, United StatesRecruiting
- Texas Oncology - Abilene - Antilley Road /ID# 280120Abilene, United StatesRecruiting
- The University of Texas MD Anderson Cancer Center /ID# 279865Houston, United StatesRecruiting
- Blue Ridge Cancer Care - Blacksburg /ID# 280115Blacksburg, United StatesRecruiting
- University Of Washington /ID# 281451Seattle, United StatesRecruiting
- Imelda Ziekenhuis /ID# 279333Bonheiden, BelgiumRecruiting
- Universitair Ziekenhuis Antwerpen /ID# 279334Edegem, BelgiumRecruiting
- Institut Jules Bordet /ID# 279406Anderlecht, BelgiumRecruiting
- Cliniques Universitaires UCL Saint-Luc /ID# 279335Brussels, BelgiumRecruiting
- Universitair Ziekenhuis Brussel /ID# 279535Jette, BelgiumRecruiting
- Grand Hopital de Charleroi - Les Viviers /ID# 279336Charleroi, BelgiumRecruiting
- Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014Yvoir, BelgiumRecruiting
And 63 more, listed on the interactive page.
- PubMed 42926107Related publication
- 2025
- 2025-521712-19-00
Related records
Drugs (4)
Lead sponsors (1)
Conditions (2)
- Colorectal cancer Primary condition
- Colorectal neoplasm