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RECRUITING
NCT06464692
PHASE1/PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-09-30

Completion Date

2028-09

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

DRUG

Telisotuzumab 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