A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06614192
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion

Study Details

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries. Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 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.

Key Dates

First listed
Sep 26, 2024
Start date
Nov 8, 2024
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telisotuzumab Adizutecan Dose A
    Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration.
  • Experimental: Telisotuzumab Adizutecan Dose B
    Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AE)s [ Time Frame: Up to a Maximum of 4 Years ]

Locations (24)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 267875DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655IrvineCalifornia92618-
USC Norris Comprehensive Cancer Center /ID# 268131Los AngelesCalifornia90033-
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175GoldenColorado80401-
Yale University School of Medicine /ID# 269125New HavenConnecticut06510-
AdventHealth Orlando /ID# 267970OrlandoFlorida32803-
Winship Cancer Institute of Emory University /ID# 266884AtlantaGeorgia30322-
St. Luke's Cancer Institute: Boise /ID# 268095BoiseIdaho83712-
Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610ChicagoIllinois60611-
Hope And Healing Cancer Services /ID# 268541HinsdaleIllinois60521-
Springfield Clinic - First /ID# 268666SpringfieldIllinois62702-
Community Cancer Center North /ID# 267965IndianapolisIndiana46250-
Hattiesburg Clinic /ID# 267860HattiesburgMississippi39401-
Washington University /ID# 267872St LouisMissouri63110-
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185BillingsMontana59102-
Rutgers Cancer Institute of New Jersey /ID# 268056New BrunswickNew Jersey08901-
University of North Carolina Medical Center /ID# 266879Chapel HillNorth Carolina27514-
Duke University Medical Center /ID# 267966DurhamNorth Carolina27710-
Avera Cancer Institute - Sioux Falls /ID# 268074Sioux FallsSouth Dakota57105-
West Cancer Center and Research Institute - Germantown /ID# 268619GermantownTennessee38138-
University of Texas - Southwestern Medical Center /ID# 268241DallasTexas75235-
Millennium Physicians /ID# 268400HoustonTexas77090-
The University of Texas MD Anderson Cancer Center /ID# 268098HoustonTexas77030-
University of Virginia /ID# 268108CharlottesvilleVirginia22908-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CALutheran Medical Center- Cancer Centers of Colorado· Golden, COYale University School of Medicine· New Haven, CTAdventHealth Orlando· Orlando, FL

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