A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer

NCT07525206 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M24-5602025-521712-19-00
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months. 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

Colorectal Cancer

Keywords

Colorectal Cancer; Telisotuzumab Adizutecan; Bevacizumab; Trifluridine and Tipiracil; AndroMETa-CRC-560

Outcome Measures

Primary Outcomes (2)

• Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)

  Confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Up to Approximately 15 Months

• Phase 3: Overall Survival (OS)

  OS is defined as the time from randomization to the event of death from any cause.

  Up to Approximately 36 Months

Secondary Outcomes (5)

• Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)

  Up to Approximately 24 Months

• Phase 3: Duration Of Response (DoR) as assessed by BICR

  Up to Approximately 24 Months

• Phase 3: Disease Control (DC) as assessed by BICR:

  Up to Approximately 24 Months

• Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13

  Up to Approximately 13 Weeks

• Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains

  Up to Approximately 13 Weeks

Study Arms (2)

Ph 3: Telisotuzumab Adizutecan + Bevacizumab

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.

Drug: Telisotuzumab adizutecan; Drug: Bevacizumab

Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab

EXPERIMENTAL

Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.

Drug: Bevacizumab; Drug: Trifluridine/Tipiracil

Interventions

Telisotuzumab adizutecan DRUG

Intravenous (IV)

Ph 3: Telisotuzumab Adizutecan + Bevacizumab

Bevacizumab DRUG

Intravenous (IV)

Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab; Ph 3: Telisotuzumab Adizutecan + Bevacizumab

Trifluridine/Tipiracil DRUG

Oral

Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
• Life expectancy \>= 12 weeks per investigator assessment

You may not qualify if:

• Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.
• History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
• History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/