Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ph 3: Telisotuzumab Adizutecan + Bevacizumab 		Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
  • Drug: Telisotuzumab adizutecan
    Intravenous (IV)
  • Drug: Bevacizumab
    Intravenous (IV)
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.
  • Drug: Bevacizumab
    Intravenous (IV)
  • Drug: Trifluridine/Tipiracil
    Oral

Recruiting Locations

City Of Hope - Phoenix /ID# 279450
Goodyear, Arizona 85338

Highlands Oncology Group - Springdale /ID# 279444
Springdale, Arkansas 72762

City of Hope National Medical Center /ID# 279449
Duarte, California 91010

Rocky Mountain Cancer Centers - Aurora /ID# 280112
Aurora, Colorado 80012

Yale University School of Medicine /ID# 279373
New Haven, Connecticut 06510

Moffitt Cancer Center /ID# 279325
Tampa, Florida 33612

City Of Hope - Atlanta /ID# 280017
Newnan, Georgia 30265

University of Chicago Medical Center /ID# 279365
Chicago, Illinois 60637

Saint Lukes Hospital of Kansas City /ID# 279513
Kansas City, Missouri 64111

Astera Cancer Care /ID# 279532
East Brunswick, New Jersey 08816-4096

Northwell Health Center for Advanced Medicine. /ID# 279590
Lake Success, New York 11042

Duke University Medical Center /ID# 279322
Durham, North Carolina 27710

Oncology Hematology Care - Blue Ash /ID# 280143
Cincinnati, Ohio 45252

Compass Oncology - Rose Quarter /ID# 280127
Portland, Oregon 97227

Texas Oncology - Abilene - Antilley Road /ID# 280120
Abilene, Texas 79606

Blue Ridge Cancer Care - Blacksburg /ID# 280115
Blacksburg, Virginia 24060

University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451
Seattle, Washington 98109

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.