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Study of Telisotuzumab Adizutecan with Chemotherapy for Metastatic Colorectal Cancer

This study is looking at a new combination treatment for metastatic colorectal cancer (cancer that has spread). It combines an investigational drug called telisotuzumab adizutecan with standard chemotherapy drugs like oxaliplatin, fluorouracil, leucovorin (often given together as FOLFOX), and either bevacizumab or panitumumab. The main goals are to see how safe this combination is and how well it shrinks tumors. You might be able to join if you are an adult with metastatic colorectal cancer, have a good performance status (meaning you can do most daily activities), and your cancer can be measured. The study aims to enroll about 390 participants. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 390 participants. It will have two stages, starting with increasing doses of telisotuzumab adizutecan to find a tolerable and effective dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events for up to approximately 6 years.

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NCT06820463

A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~390 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Telisotuzumab AdizutecanFluorouracilOxaliplatinLeucovorinBevacizumabPanitumumab

At a glance

Recruiting sites
65 of 65 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.
Measured over Up to 24 Weeks
+1 more outcome measured

Conditions

Metastatic Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

65 sites across 49 states
Taiwan6
Israel3
Spain3
California2
Illinois2
Texas2
São Paulo2
Brazil2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Laboratory values meeting the criteria within the protocol.
Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Exclusion

Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan).
History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

What this trial measures

  • Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.Up to 24 Weeks

    OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.

  • Number of Participants with Adverse Events (AE)sUp to Approximately 6 Years

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.