Colorectal Cancer Clinical Trial
Official title:
A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of ABBV-400 in Chinese Subjects With Unresectable Locally Advanced/Metastatic Colorectal Cancer
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 ABBV-400 moves through the body of adult participants with unresectable locally advanced/metastatic CRC. ABBV-400 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 ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Up to approximately 27 adult participants with unresectable locally advanced/metastatic CRC, will be enrolled in the study in approximately 10 sites in China. In the dose escalation arms, participants will receive escalating doses of intravenously (IV) infused ABBV-400 dose A or B. In dose expansion arm part 1, participants will receive the optimal dose of IV infused ABBV-400. In dose expansion arm part 2, participants will receive the dose B of IV infused ABBV-400. 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.
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