A Study to Assess Adverse Events and Change in Disease Ac... | NCT07023289

Studies
A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease

NCT07023289

Sponsor

AbbVie

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

140Estimated

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

Telisotuzumab Adizutecan
Standard of Care

Countries

United States
Belgium
Denmark
Italy
Japan
South Korea
Spain
Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2024-518015-19-00	Other Identifier	EU CT

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2025Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2029Estimated

First Submitted Date

Jun 10, 2025

First Submission Date that Met QC Criteria

Jun 10, 2025

First Posted Date

Jun 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone.

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide.

In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telisotuzumab Adizutecan Monotherapy	Experimental	Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.	Drug: Telisotuzumab Adizutecan
Standard of Care (SOC)	Active Comparator	Participants will receive SOC, during the approximately 51 month study duration.	Drug: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telisotuzumab Adizutecan	Drug	Intravenous (IV) Infusion	Telisotuzumab Adizutecan Monotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with disease free survival (DFS) Event	DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.	Up to Approximately 51 Months

Secondary Outcomes

Measure	Description	Time Frame
Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months	ctDNA clearance at 6 months is defined as ctDNA negative at 6 months after randomization.	6 Months
Overall Survival (OS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
Surgical tumor material should be available for Signatera ctDNA personalized panel design.
Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.
Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.
Circulating tumor deoxyribonucleic acid (ctDNA) positive within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity is confirmed (reported).
For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy.

Exclusion Criteria:

No availability of surgical tissue sample.
History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
ABBVIE CALL CENTER	Contact	844-663-3742		abbvieclinicaltrials@abbvie.com

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621	Recruiting	Huntsville	Alabama	35805	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Types

Study Protocol
Statistical Analysis Plan (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/

URL

https://vivli.org/ourmember/abbvie/

ID	Term
D015179	Colorectal Neoplasms
D009369	Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation