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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
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
Conditions
Interventions
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