OncoMatch

OncoMatch/Clinical Trials/NCT06614192

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

Is NCT06614192 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Telisotuzumab Adizutecan and Trifluridine/Tipiracil for metastatic colorectal cancer.

Phase 3RecruitingAbbVieNCT06614192Data as of May 2026

Treatment: Telisotuzumab Adizutecan · Trifluridine/Tipiracil · BevacizumabColorectal 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MET overexpression (protein above cutoff level)

c-Met protein above cutoff level

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: c-MET targeting antibody

Prior systemic regimen containing c-MET targeting antibody

Cannot have received: c-MET targeting bispecific

Prior systemic regimen containing c-MET targeting bispecific

Cannot have received: c-MET targeting antibody-drug conjugate

Prior systemic regimen containing c-Met targeting Antibody Drug Conjugate [ADC]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope National Medical Center /ID# 267875 · Duarte, California
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655 · Irvine, California
  • USC Norris Comprehensive Cancer Center /ID# 268131 · Los Angeles, California
  • Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 · Golden, Colorado
  • Yale New Haven Hospital /ID# 269125 · New Haven, Connecticut

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