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Not recruiting
Phase 3

ABBV-400 vs. LONSURF

Sponsor:

AbbVie

Code:

NCT06614192

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Study Details

Brief 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 and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan 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 and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries.

Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. 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

Metastatic Colorectal Cancer

Study ID

NCT06614192

Start date

Nov 8, 2024

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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/bispecific or Antibody Drug Conjugate (c-Met targeting 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.

Study Design

Enrollment

74 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telisotuzumab Adizutecan Dose A

Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration.

experimental: Telisotuzumab Adizutecan Dose B

Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Primary outcome measure

  • Percentage of Participants with Adverse Events (AE)s [ Time Frame: Up to a Maximum of 4 Years ]
  • Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator [ Time Frame: Up to a Maximum of 4 Years ]
  • Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator [ Time Frame: Up to a Maximum of 4 Years ]
  • Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator [ Time Frame: Up to a Maximum of 4 Years ]
  • Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to a Maximum of 4 Years ]
  • Overall Survival (OS) [ Time Frame: Up to a Maximum of 4 Years ]

Central Contacts and Locations

More Information

Sponsor

AbbVie

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Metastatic Colorectal Cancer
  • Telisotuzumab Adizutecan
  • ABBV-400
  • AndroMETa-CRC-064

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-28.