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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
NCT06614192 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06614192 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Illinois, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06614192?
The interventions under investigation include: Bevacizumab (DRUG), Telisotuzumab Adizutecan (DRUG), Trifluridine/Tipiracil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06614192?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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