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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: Recruiting Phase 3 study of Metastatic Colorectal Cancer, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.
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 |
What NCT06614192 shows while recruiting
NCT06614192 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, above the 176-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (161% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06614192's enrollment target sits among peer trials
460 6th of 45 higher than 40 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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