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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Sep 2025 → ongoing

Decision date (initial)

2026-02-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others, Pharmacokinetic

To evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by disease free survival (DFS) by investigator.

Secondary objectives 4

1. To evaluate clinical outcomes of telisotuzumab adizutecan monotherapy as measured by circulating tumor deoxyribonucleic acid (ctDNA) clearance rate at 6 months.
2. To evaluate clinical outcomes of telisotuzumab adizutecan monotherapy as measured by overall survival (OS).
3. To evaluate the safety and tolerability of telisotuzumab adizutecan monotherapy.
4. To evaluate the pharmacokinetics (PK) and immunogenicity of telisotuzumab adizutecan monotherapy.

Conditions and MedDRA coding

Colorectal Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan 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. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
2. Surgical tumor material should be available and must be submitted for Signatera™ personalized panel and assessment of c-Met protein levels.
3. 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.
4. 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.
5. Circulating tumor deoxyribonucleic acid (ctDNA) positive after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA is confirmed (reported).

Exclusion criteria 3

1. No availability of surgical tissue sample.
2. 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.
3. Treated or untreated brain or meningeal metastases.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of Participants with disease free survival (DFS) Event

Secondary endpoints 2

1. Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
2. Overall Survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 10

Locations

4 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications