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 (NCT06614192)
AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center /ID# 267875 โ Duarte, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (51 Sites)
Showing the first 25 of 51 sites.
- City of Hope National Medical Center /ID# 267875 โ Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655 โ Irvine, California
- USC Norris Comprehensive Cancer Center /ID# 268131 โ Los Angeles, California
- Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 โ Golden, Colorado
- Yale University School of Medicine /ID# 269125 โ New Haven, Connecticut
- AdventHealth Orlando /ID# 267970 โ Orlando, Florida
- Winship Cancer Institute of Emory University /ID# 266884 โ Atlanta, Georgia
- St. Luke's Cancer Institute: Boise /ID# 268095 โ Boise, Idaho
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610 โ Chicago, Illinois
- Hope And Healing Cancer Services /ID# 268541 โ Hinsdale, Illinois
- Springfield Clinic - First /ID# 268666 โ Springfield, Illinois
- Community Cancer Center North /ID# 267965 โ Indianapolis, Indiana
- Hattiesburg Clinic /ID# 267860 โ Hattiesburg, Mississippi
- Washington University /ID# 267872 โ St Louis, Missouri
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185 โ Billings, Montana
- Rutgers Cancer Institute of New Jersey /ID# 268056 โ New Brunswick, New Jersey
- University of North Carolina Medical Center /ID# 266879 โ Chapel Hill, North Carolina
- Duke University Medical Center /ID# 267966 โ Durham, North Carolina
- Avera Cancer Institute - Sioux Falls /ID# 268074 โ Sioux Falls, South Dakota
- West Cancer Center and Research Institute - Germantown /ID# 268619 โ Germantown, Tennessee
- University of Texas - Southwestern Medical Center /ID# 268241 โ Dallas, Texas
- The University of Texas MD Anderson Cancer Center /ID# 268098 โ Houston, Texas
- Millennium Physicians /ID# 268400 โ Houston, Texas
- University of Virginia /ID# 268108 โ Charlottesville, Virginia
- Mater Hospital Brisbane /ID# 268360 โ South Brisbane, Queensland
๐ Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.