A study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination with IV Bevacizumab Compared to Standard of Care IV Bevacizumab in combination with Oral Trifluridine and Tipiracil in Adult Participants with Refractory Metastatic Colorectal Cancer

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

6 Jul 2026 → ongoing

Decision date (initial)

2026-06-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

- To demonstrate the superiority of telisotuzumab adizutecan + bevacizumab over trifluridine and tipiracil + bevacizumab in terms of Objective Response (OR).
- To demonstrate the superiority of telisotuzumab adizutecan + bevacizumab over trifluridine and tipiracil + bevacizumab in terms of Overall Survival (OS).

Secondary objectives 4

1. To evaluate the efficacy as measured by Progression-Free Survival (PFS) of telisotuzumab adizutecan + bevacizumab in participants with unresectable refractory metastatic colorectal cancer (mCRC).
2. To evaluate the impact of telisotuzumab adizutecan + bevacizumab on key patient-reported outcomes (PROs) by assessing physical functioning and overall quality of life (QoL) from the participant's perspective.
3. To evaluate the safety of telisotuzumab adizutecan + bevacizumab in participant's with unresectable refractory mCRC.
4. To evaluate clinical outcomes such as duration of response (DoR) and disease control (DC) of telisotuzumab adizutecan + bevacizumab in participants with unresectable refractory mCRC.

Conditions and MedDRA coding

Colorectal Cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

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 the following link 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 2

1. Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
2. Life expectancy >= 12 weeks per investigator assessment

Exclusion criteria 4

1. Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.
2. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
3. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
4. History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
2. Phase 3: Overall Survival (OS)

Secondary endpoints 5

1. Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)
2. Phase 3: Duration Of Response (DoR) as assessed by BICR
3. Phase 3: Disease Control (DC) as assessed by BICR:
4. Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13
5. Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains

Investigational products

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

Test 2

Comparator 3

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 8

Locations

5 EU/EEA countries · 39 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 49 files

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

Application history

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