Recruiting
Phase 3

Telisotuzumab & Bevacizumab

Sponsor:

AbbVie

Code:

NCT07525206

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab adizutecan

Bevacizumab

Trifluridine/Tipiracil

Study Details

Brief 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.

Conditions

Colorectal Cancer

Study ID

NCT07525206

Start date

May 22, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

990 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ph 3: Telisotuzumab Adizutecan + Bevacizumab

Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.

experimental: Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab

Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.

Interventions

Telisotuzumab adizutecan

Intravenous (IV)

Bevacizumab

Intravenous (IV)

Trifluridine/Tipiracil

Oral

Primary outcome measure

  • Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to Approximately 15 Months ]
  • Phase 3: Overall Survival (OS) [ Time Frame: Up to Approximately 36 Months ]

Central Contacts and Locations

Central contacts

Locations

City Of Hope - Phoenix /ID# 279450

Recruiting

Goodyear, Arizona, United States, 85338

Highlands Oncology Group - Springdale /ID# 279444

Recruiting

Springdale, Arkansas, United States, 72762

City of Hope National Medical Center /ID# 279449

Recruiting

Duarte, California, United States, 91010

Rocky Mountain Cancer Centers - Aurora /ID# 280112

Recruiting

Aurora, Colorado, United States, 80012

Yale University School of Medicine /ID# 279373

Recruiting

New Haven, Connecticut, United States, 06510

Moffitt Cancer Center /ID# 279325

Recruiting

Tampa, Florida, United States, 33612

City Of Hope - Atlanta /ID# 280017

Recruiting

Newnan, Georgia, United States, 30265

University of Chicago Medical Center /ID# 279365

Recruiting

Chicago, Illinois, United States, 60637

Saint Lukes Hospital of Kansas City /ID# 279513

Recruiting

Kansas City, Missouri, United States, 64111

Astera Cancer Care /ID# 279532

Recruiting

East Brunswick, New Jersey, United States, 08816-4096

Northwell Health Center for Advanced Medicine. /ID# 279590

Recruiting

Lake Success, New York, United States, 11042

Duke University Medical Center /ID# 279322

Recruiting

Durham, North Carolina, United States, 27710

Oncology Hematology Care - Blue Ash /ID# 280143

Recruiting

Cincinnati, Ohio, United States, 45252

Compass Oncology - Rose Quarter /ID# 280127

Recruiting

Portland, Oregon, United States, 97227

Texas Oncology - Abilene - Antilley Road /ID# 280120

Recruiting

Abilene, Texas, United States, 79606

The University of Texas MD Anderson Cancer Center /ID# 279865

Recruiting

Houston, Texas, United States, 77030

Blue Ridge Cancer Care - Blacksburg /ID# 280115

Recruiting

Blacksburg, Virginia, United States, 24060

University Of Washington /ID# 281451

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

AbbVie

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Colorectal Cancer
  • Telisotuzumab Adizutecan
  • Bevacizumab
  • Trifluridine and Tipiracil
  • AndroMETa-CRC-560

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.