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 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M24-0642024-512804-20-00
• Study Type: interventional
• Target: 460
• Locations: 7 countries
• Sites: 51

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 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

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer; Telisotuzumab Adizutecan; ABBV-400; Trifluridine; Tipiracil; LONSURF; Bevacizumab; AndroMETa-CRC-064

Outcome Measures

Primary Outcomes (6)

• Stage 1: Percentage of Participants with Adverse Events (AE)s

  An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.

  Up to a Maximum of 4 Years

• Stage 1: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator

  Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.

  Up to a Maximum of 4 Years

• Stage 1: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator

  Percentage of participants with clinically significant ECGs findings as assessed by the investigator.

  Up to a Maximum of 4 Years

• Stage 1: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator

  Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.

  Up to a Maximum of 4 Years

• Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)

  OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

  Up to a Maximum of 4 Years

• Stage 2: Overall Survival (OS)

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

  Up to a Maximum of 4 Years

Secondary Outcomes (21)

• Stage 1 and Stage 2: Progression Free Survival (PFS) as Assessed by BICR

  Up to a Maximum of 4 Years

• Stage 1: OS

  Up to a Maximum of 4 Years

• Stage 1 and Stage 2: Duration of Response (DOR) as Assessed by BICR

  Up to a Maximum of 4 Years

• Stage 1 and Stage 2: Disease Control (DC) as Assessed by BICR

  Up to a Maximum of 4 Years

• Stage 1 and Stage 2: OR as Assessed by Investigator

  Up to a Maximum of 4 Years

Study Arms (4)

Stage 1: Telisotuzumab Adizutecan Dose A

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Stage 1: Telisotuzumab Adizutecan Dose B

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Stage 2: Telisotuzumab Adizutecan Optimal Dose

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Stage 2: Standard of Care (SOC)

EXPERIMENTAL

Participants will receive the SOC, as part of the approximately 4 year study duration.

Drug: Trifluridine/Tipiracil; Drug: Bevacizumab

Interventions

Telisotuzumab Adizutecan DRUG

Intravenous (IV) Infusion

Stage 1: Telisotuzumab Adizutecan Dose A; Stage 1: Telisotuzumab Adizutecan Dose B; Stage 2: Telisotuzumab Adizutecan Optimal Dose

Trifluridine/Tipiracil DRUG

Oral Tablet

Also known as: LONSURF

Stage 2: Standard of Care (SOC)

Bevacizumab DRUG

IV Infusion

Stage 2: Standard of Care (SOC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (51)

City of Hope National Medical Center /ID# 267875

Duarte, California, 91010, United States

RECRUITING

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655

Irvine, California, 92618, United States

RECRUITING

USC Norris Comprehensive Cancer Center /ID# 268131

Los Angeles, California, 90033, United States

RECRUITING

Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175

Golden, Colorado, 80401, United States

RECRUITING

Yale New Haven Hospital /ID# 269125

New Haven, Connecticut, 06510, United States

RECRUITING

AdventHealth Orlando /ID# 267970

Orlando, Florida, 32803, United States

RECRUITING

Winship Cancer Institute of Emory University /ID# 266884

Atlanta, Georgia, 30322, United States

RECRUITING

St. Luke's Cancer Institute: Boise /ID# 268095

Boise, Idaho, 83712, United States

RECRUITING

Northwestern Memorial Hospital /ID# 268610

Chicago, Illinois, 60611-2927, United States

RECRUITING

Hope And Healing Cancer Services /ID# 268541

Hinsdale, Illinois, 60521, United States

RECRUITING

Springfield Clinic - First /ID# 268666

Springfield, Illinois, 62702, United States

RECRUITING

Community Cancer Center North /ID# 267965

Indianapolis, Indiana, 46250, United States

RECRUITING

Hattiesburg Clinic /ID# 267860

Hattiesburg, Mississippi, 39401, United States

RECRUITING

Washington University /ID# 267872

St Louis, Missouri, 63110, United States

RECRUITING

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185

Billings, Montana, 59102, United States

RECRUITING

Rutgers Cancer Institute of New Jersey /ID# 268056

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of North Carolina Medical Center /ID# 266879

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Duke University Medical Center /ID# 267966

Durham, North Carolina, 27710, United States

RECRUITING

Avera Cancer Institute - Sioux Falls /ID# 268074

Sioux Falls, South Dakota, 57105, United States

RECRUITING

West Cancer Center and Research Institute - Germantown /ID# 268619

Germantown, Tennessee, 38138, United States

RECRUITING

University of Texas - Southwestern Medical Center /ID# 268241

Dallas, Texas, 75235, United States

RECRUITING

The University of Texas MD Anderson Cancer Center /ID# 268098

Houston, Texas, 77030, United States

RECRUITING

Millennium Research & Clinical Development /ID# 268400

Houston, Texas, 77090, United States

COMPLETED

University of Virginia /ID# 268108

Charlottesville, Virginia, 22908, United States

RECRUITING

Mater Hospital Brisbane /ID# 268360

South Brisbane, Queensland, 4101, Australia

RECRUITING

The Chaim Sheba Medical Center /ID# 267741

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 267578

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

Rambam Health Care Campus /ID# 267739

Haifa, 3525408, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 267579

Jerusalem, 91120, Israel

RECRUITING

Rabin Medical Center /ID# 267740

Petah Tikva, 4941492, Israel

RECRUITING

Assuta Medical Center /ID# 267745

Tel Aviv, 6789140, Israel

RECRUITING

Aichi Cancer Center /ID# 268237

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East /ID# 268236

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

The University of Osaka Hospital /ID# 268743

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Saitama Prefectural Cancer Center /ID# 268706

Kitaadachi-gun, Saitama, 362-0806, Japan

RECRUITING

National Cancer Center Hospital /ID# 268713

Chuo-Ku, Tokyo, 104-0045, Japan

RECRUITING

Pan American Center for Oncology Trials /ID# 267888

Rio Piedras, 00935, Puerto Rico

RECRUITING

Seoul National University Bundang Hospital /ID# 268592

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Seoul National University Hospital /ID# 268719

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 268718

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Asan Medical Center /ID# 268717

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Samsung Medical Center /ID# 268720

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Kaohsiung Chang Gung Memorial Hospital /ID# 267638

Kaohsiung City, Kaohsiung, 833, Taiwan

RECRUITING

National Taiwan University Hospital /ID# 267627

Taipei City, Taipei, 100, Taiwan

RECRUITING

Changhua Christian Hospital /ID# 270464

Changhua City, Changhua County, 50006, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635

Kaohsiung City, 807, Taiwan

RECRUITING

China Medical University Hospital /ID# 267631

Taichung, 404, Taiwan

RECRUITING

Taichung Veterans General Hospital /ID# 270467

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital /ID# 270468

Tainan, 704, Taiwan

RECRUITING

Taipei Veterans General Hospital /ID# 267628

Taipei, 112, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 267637

Taoyuan, 333, Taiwan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combination; Bevacizumab

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 26, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

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/

Locations

TW (9); KR (5); IL (6); US (24); AU (1); JP (5); PR (1)