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NCT06614192 · ClinicalTrials.gov registry record · Phase 3
A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
A Phase 3 study of Metastatic Colorectal Cancer, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
- 20
- Study locations
NCT06614192 is a Phase 3 study of Metastatic Colorectal Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 460 participants, above the 176-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (161% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT06614192, a Phase 3 study of Metastatic Colorectal Cancer, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 disease activity when comparing intravenously (IV) infused telisotuzumab adizutecan to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab 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 as part of 2 stages. Each treatment arm in stage 1 receives a different dose of telisotuzumab adizutecan. Each treatment arm in stage 2 receives the optimal dose of telisotuzumab adizutecan or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries. In stage 1, participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. In stage 2, participants will receive the optimal dose of IV infused telisotuzumab adizutecan or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. 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.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Telisotuzumab Adizutecan
- DRUG Trifluridine/Tipiracil
Study Locations (20)
California
- City of Hope National Medical Center /ID# 267875 - Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655 - Irvine
- USC Norris Comprehensive Cancer Center /ID# 268131 - Los Angeles
Illinois
- Northwestern Memorial Hospital /ID# 268610 - Chicago
- Hope And Healing Cancer Services /ID# 268541 - Hinsdale
- Springfield Clinic - First /ID# 268666 - Springfield
North Carolina
- University of North Carolina Medical Center /ID# 266879 - Chapel Hill
- Duke University Medical Center /ID# 267966 - Durham
Colorado
- Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 - Golden
Connecticut
- Yale New Haven Hospital /ID# 269125 - New Haven
Florida
- AdventHealth Orlando /ID# 267970 - Orlando
Georgia
- Winship Cancer Institute of Emory University /ID# 266884 - Atlanta
Idaho
- St. Luke's Cancer Institute: Boise /ID# 268095 - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2024-11-08 |
| Est. Completion | 2028-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06614192
The ClinicalTrials.gov registry entry for NCT06614192 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 176-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (161% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT06614192 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06614192 about?
NCT06614192 is a clinical study titled "A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer". 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 disease activity when comparing intravenously (IV) infused telisotuzumab adizutecan to trifluridine and tipiracil (LONSURF) oral tablets plus IV inf...
What is the current status of trial NCT06614192?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2024-11-08. Estimated completion is 2028-10.
What conditions does trial NCT06614192 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT06614192?
The interventions under investigation include: Bevacizumab (DRUG), Telisotuzumab Adizutecan (DRUG), Trifluridine/Tipiracil (DRUG).
Who is sponsoring clinical trial NCT06614192?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06614192 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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