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

Phase 2

Not yet recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Telisotuzumab Adizutecan; Drug: Standard of Care

• Registration Number: NCT07023289
• Lead Sponsor: AbbVie

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 available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-16
• Last Update Posted: 2025-06-16
• Study Start: 2025-09-05
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
• Surgical tumor material should be available and must be submitted for Signatera personalized panel and assessment of c-Met protein levels.
• Must have received at least 3 months of platinum-based doublet adjuvant 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 after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA 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.
• For participants with oligometastatic disease a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet therapy must have been administered.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telisotuzumab Adizutecan Monotherapy	Telisotuzumab Adizutecan	Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.
Standard of Care (SOC)	Standard of Care	Participants will receive SOC, during the approximately 51 month study duration.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with disease free survival (DFS) Event	Up to Approximately 51 Months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months	6 Months	ctDNA clearance at 6 months is defined as ctDNA negative at 6 months after randomization.
Overall Survival (OS)	Up to Approximately 51 Months	OS is defined as the time from randomization to the event of death from any cause.