A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

NCT06614192 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M24-0642024-512804-20-00
• Study Type: interventional
• Target: 74
• 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 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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 (15)

• Progression Free Survival (PFS) as Assessed by BICR

  Up to a Maximum of 4 Years

• OS

  Up to a Maximum of 4 Years

• Duration of Response (DOR) as Assessed by BICR

  Up to a Maximum of 4 Years

• Disease Control (DC) as Assessed by BICR

  Up to a Maximum of 4 Years

• OR as Assessed by Investigator

  Up to a Maximum of 4 Years

Study Arms (2)

Telisotuzumab Adizutecan Dose A

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Telisotuzumab Adizutecan Dose B

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Interventions

Telisotuzumab Adizutecan DRUG

Intravenous (IV) Infusion

Telisotuzumab Adizutecan Dose A; Telisotuzumab Adizutecan Dose B

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

Location

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

Irvine, California, 92618, United States

Location

USC Norris Comprehensive Cancer Center /ID# 268131

Los Angeles, California, 90033, United States

Location

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

Golden, Colorado, 80401, United States

Location

Yale University School of Medicine /ID# 269125

New Haven, Connecticut, 06510, United States

Location

AdventHealth Orlando /ID# 267970

Orlando, Florida, 32803, United States

Location

Winship Cancer Institute of Emory University /ID# 266884

Atlanta, Georgia, 30322, United States

Location

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

Boise, Idaho, 83712, United States

Location

Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610

Chicago, Illinois, 60611, United States

Location

Hope And Healing Cancer Services /ID# 268541

Hinsdale, Illinois, 60521, United States

Location

Springfield Clinic - First /ID# 268666

Springfield, Illinois, 62702, United States

Location

Community Cancer Center North /ID# 267965

Indianapolis, Indiana, 46250, United States

Location

Hattiesburg Clinic /ID# 267860

Hattiesburg, Mississippi, 39401, United States

Location

Washington University /ID# 267872

St Louis, Missouri, 63110, United States

Location

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

Billings, Montana, 59102, United States

Location

Rutgers Cancer Institute of New Jersey /ID# 268056

New Brunswick, New Jersey, 08901, United States

Location

University of North Carolina Medical Center /ID# 266879

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center /ID# 267966

Durham, North Carolina, 27710, United States

Location

Avera Cancer Institute - Sioux Falls /ID# 268074

Sioux Falls, South Dakota, 57105, United States

Location

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

Germantown, Tennessee, 38138, United States

Location

University of Texas - Southwestern Medical Center /ID# 268241

Dallas, Texas, 75235, United States

Location

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

Houston, Texas, 77030, United States

Location

Millennium Physicians /ID# 268400

Houston, Texas, 77090, United States

Location

University of Virginia /ID# 268108

Charlottesville, Virginia, 22908, United States

Location

Mater Hospital Brisbane /ID# 268360

South Brisbane, Queensland, 4101, Australia

Location

Rabin Medical Center. /ID# 267740

Petah Tikva, Central District, 4941492, Israel

Location

The Chaim Sheba Medical Center /ID# 267741

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 267578

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Assuta Medical Center - Tel Aviv /ID# 267745

Tel Aviv, Tel Aviv, 6789140, Israel

Location

Rambam Health Care Campus- Haifa /ID# 267739

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 267579

Jerusalem, 91120, Israel

Location

Aichi Cancer Center /ID# 268237

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East /ID# 268236

Kashiwa-shi, Chiba, 277-8577, Japan

Location

The University of Osaka Hospital /ID# 268743

Suita-shi, Osaka, 565-0871, Japan

Location

Saitama Prefectural Cancer Center /ID# 268706

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Cancer Center Hospital /ID# 268713

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Pan American Center for Oncology Trials - Rio Piedras /ID# 267888

Rio Piedras, 00935, Puerto Rico

Location

Seoul National University Bundang Hospital /ID# 268592

Seongnam-si, Gyeonggido, 13620, South Korea

Location

Seoul National University Hospital /ID# 268719

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 268718

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center /ID# 268717

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 268720

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Changhua Christian Hospital /ID# 270464

Changhua City, Changhua County, 50006, Taiwan

Location

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

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 267638

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital /ID# 267631

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital /ID# 270467

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital /ID# 270468

Tainan, 704, Taiwan

Location

National Taiwan University Hospital /ID# 267627

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital /ID# 267628

Taipei, 112, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 267637

Taoyuan City, 333, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

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: September 25, 2024
• First Posted: September 26, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

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

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