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 Refractory Metastatic Colorectal Cancer expressing c-Met Protein Level Above Cutoff

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

completed 1 May 2026

Decision date (initial)

2025-12-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Abbvie

External identifiers

EU CT number

2024-512804-20-00

ClinicalTrials.gov

NCT06614192

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

Stage 1: To optimize telisotuzumab adizutecan monotherapy dose to determine the recommended dose in participants with unresectable refractory metastatic colorectal cancer (mCRC) selected for the defined level of c-Met protein expression; To evaluate the efficacy of telisotuzumab adizutecan monotherapy dose as measured by objective response (OR) in participants with unresectable refractory mCRC selected for the defined level of c-Met protein expression.; To evaluate the safety of telisotuzumab adizutecan monotherapy in participants with unresectable refractory mCRC selected for the defined level of c-Met protein expression;
Stage 2: To demonstrate the superiority of telisotuzumab adizutecan over LONSURF (Trifluridine and Tipiracil) plus bevacizumab in terms of objective response (OR); To demonstrate the superiority of telisotuzumab adizutecan over LONSURF (Trifluridine and Tipiracil) plus bevacizumab in terms of overall survival (OS).

Secondary objectives 7

1. Stage 1: To evaluate the efficacy as measured by progression free survival (PFS), and overall survival (OS) of telisotuzumab adizutecan monotherapy.
2. Stage 1: To evaluate clinical outcomes such as duration of response (DOR), disease control rate (DCR) of telisotuzumab adizutecan monotherapy.
3. Stage 1: To evaluate the pharmacokinetic (PK) profile of telisotuzumab adizutecan monotherapy.
4. Stage 2: To evaluate the efficacy as measured by progression free survival (PFS) of telisotuzumab adizutecan monotherapy.
5. Stage 2: To evaluate the impact of telisotuzumab adizutecan on key patient-reported outcomes (PROs) by assessing symptoms, functional impacts and overall quality of life (QoL) from the participant's perspective.
6. Stage 2: To evaluate the safety of telisotuzumab adizutecan monotherapy.
7. Stage 2: To evaluate clinical outcomes such as duration of response (DOR), disease control rate (DCR) of telisotuzumab adizutecan monotherapy.

Conditions and MedDRA coding

Metastatic Colorectal Cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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 3

1. Life expectancy >= 12 weeks per investigator assessment.
2. 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.
3. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Exclusion criteria 3

1. Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate [ADC]).
2. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
3. Active infection as noted in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Stage 1: Percentage of Participants with Adverse Events (AE)s
2. Stage 1: Percentage of Participants with With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
3. Stage 1: Percentage of Participants with PCS Electrocardiograms (ECGs) Findings as Assessed by the Investigator
4. Stage 1: Percentage of Participants with PCS Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
5. Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
6. Stage 2: Overall Survival (OS)

Secondary endpoints 22

1. Stage 1 and Stage 2: Progression Free Survival (PFS) as Assessed by BICR
2. Stage 1: OS
3. Stage 1 and Stage 2: Duration of Response (DOR) as Assessed by BICR
4. Stage 1 and Stage 2: Disease Control (DC) as Assessed by BICR
5. Stage 1 and Stage 2: OR as Assessed by Investigator
6. Stage 1 and Stage 2: PFS as Assessed by Investigator
7. Stage 1 and Stage 2: DOR as Assessed by Investigator
8. Stage 1: Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan
9. Stage 1: Time to Cmax (Tmax) for Telisotuzumab Adizutecan
10. Stage 1: Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan
11. Stage 1: Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan
12. Stage 1: Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan
13. Stage 1: Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan
14. Stage 1: Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan
15. Stage 1: Neutralizing Anti-Drug Antibodies (nADAs) for Telisotuzumab Adizutecan
16. Stage 2: Change from Baseline at C5D1 in Physical Functioning as Measured by the Physical Functioning Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
17. Stage 2: Change from Baseline at C7D1 (Standard of Care [SOC] Arm) in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
18. Stage 2: Change from Baseline at C5D1 in in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
19. Stage 2: Change from Baseline at C7D1 (SOC Arm) in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
20. Stage 2: Change from Baseline at C5D1 in in Global Health Status (GHS)/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
21. Stage 2: Change from Baseline at C7D1 (SOC Arm) in GHS/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
22. Stage 1 and Stage 2: DC as Assessed by Investigator

Investigational products

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

Test 1

Comparator 4

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 5

Locations

6 EU/EEA countries · 41 investigational sites

By country

Investigational sites

Results and documents

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

Documents 49 files

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

Application history

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