A Randomized Trial 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 Over-Expressed Refractory Metastatic Colorectal Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT06614192
This trial evaluates adverse events and disease activity in c-Met over-expressed refractory mCRC. Participants receive ABBV-400 or LONSURF plus bevacizumab. Eligibility includes a life expectancy of ≥12 weeks, ECOG PS 0-1, and measurable disease per RECIST 1.1. Interventions involve IV ABBV-400, oral LONSURF, and IV bevacizumab.
Patient Parameters
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Program Overview
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 ABBV-400 to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).
ABBV-400 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 ABBV-400. Each treatment arm in stage 2 receives the optimal dose of ABBV-400 or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met over-expressed (OE) 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 ABBV-400 dose A or B. In stage 2, participants will receive the optimal dose of IV infused ABBV-400 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.
Eligibility Criteria
Inclusion Criteria
- Life expectancy >= 12 weeks per investigator assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Exclusion Criteria
- Prior systemic regimen containing c-MET targeting antibody or Antibody Drug Conjugate (ADC).
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
- Active infection as noted in the protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center /ID# 267875 | 91010 | Duarte | California |
| City of Hope Orange County Lennar Foundation Cancer Center /ID# 270655 | 92618 | Irvine | California |
| USC Norris Comprehensive Cancer Center /ID# 268131 | 90033 | Los Angeles | California |
| Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 | 80401 | Golden | Colorado |
| Yale New Haven Hospital /ID# 269125 | 06510 | New Haven | Connecticut |
| AdventHealth Orlando /ID# 267970 | 32803 | Orlando | Florida |
| St. Luke's Cancer Institute: Boise /ID# 268095 | 83712 | Boise | Idaho |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 268610 | 60611-2927 | Chicago | Illinois |
| Hope And Healing Cancer Services /ID# 268541 | 60521 | Hinsdale | Illinois |
| Springfield Clinic /ID# 268666 | 62702-3749 | Springfield | Illinois |
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