RecruitingPhase 1Phase 2NCT06464692

Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer

A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of Telisotuzumab Adizutecan (ABBV-400) in Chinese Subjects With Unresectable Locally Advanced/Metastatic Colorectal Cancer


Sponsor

AbbVie

Enrollment

30 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and how telisotuzumab adizutecan moves through the body of adult participants with unresectable locally advanced/metastatic CRC. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Study doctors put the participants in cohorts called treatment arms. Each treatment arm receives a different dose of telisotuzumab adizutecan. This study will include a dose escalation phase followed by a dose expansion phase. Up to approximately 30 adult participants with unresectable locally advanced/metastatic CRC, will be enrolled in the study in approximately 8 sites in China. In the dose escalation arms, participants will receive escalating doses of intravenously (IV) infused telisotuzumab adizutecan dose A or B. In dose expansion arm part 1, participants will receive dose A of IV infused telisotuzumab adizutecan. In dose expansion arm part 2, participants will receive the dose C of IV infused telisotuzumab adizutecan. The total study duration will be approximately 2.5 years. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug treatment (telisotuzumab adizutecan) for people with advanced or metastatic colorectal cancer that can't be surgically removed. It aims to assess safety and how the drug moves through the body. **You may be eligible if...** - You have been confirmed to have advanced or metastatic colorectal cancer - You are generally in good health (ECOG score 0 or 1) - Your cancer does not have specific mutations: no BRAF V600E mutation, and is not MSI-High/dMMR **You may NOT be eligible if...** - Your cancer has certain genetic markers (BRAF V600E mutation or high microsatellite instability) - You have not received standard prior therapies as required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTelisotuzumab Adizutecan

Intravenous (IV) Infusion


Locations(8)

Beijing Cancer Hospital /ID# 263297

Beijing, Beijing Municipality, China

The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 263309

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital /ID# 263049

Harbin, Heilongjiang, China

Henan Cancer Hospital /ID# 263172

Zhengzhou, Henan, China

Hubei Cancer Hospital /ID# 263248

Wuhan, Hubei, China

The First Affiliated Hospital of Nanchang University /ID# 263193

Nanchang, Jiangxi, China

First Affiliated Hospital of China Medical University /ID# 263338

Shenyang, Liaoning, China

The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 263094

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06464692


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