Telisotuzumab Adizutecan
DrugIntravenous (IV) Infusion
NCT Number: NCT06464692
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing Cancer Hospital /ID# 263297, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous (IV) Infusion
Time frame: Up to 24 Months
DLTs are defined as grade >= 3 thrombocytopenia that cannot clinically improve after adequate medical treatment/support, febrile neutropenia grade >= 3 or grade 4 neutropenia that cannot clinically improve after adequate medical treatment/support, and any grade 2 or higher interstitial lung disease (ILD)/pneumonitis that cannot clinically improve after adequate medical treatment/support.
Time frame: Up to 24 Months
Cmax of telisotuzumab adizutecan conjugate.
Time frame: Up to 24 Months
Tmax of telisotuzumab adizutecan conjugate.
Time frame: Up to 24 Months
AUC of telisotuzumab adizutecan conjugate.
Time frame: Up to 24 Months
Total antibody of telisotuzumab adizutecan.
Time frame: Up to 24 Months
Unconjugated payload of telisotuzumab adizutecan.
Time frame: Up to 24 Months
OR as assessed by the Investigator: Confirmed complete response (CR) or confirmed partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Time frame: Up to 24 Months
DoR as assessed by Investigator: DoR is defined as the time from the participantt's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.
Time frame: Up to 24 Months
Disease control as assessed by the Investigator: BOR of confirmed CR or confirmed PR, or stable disease based on RECIST, version 1.1.
Time frame: Up to 24 Months
PFS as assessed by Investigator: PFS is defined as the time from the participant's first dose of study treatment until radiographic progression or death from any cause, whichever occurs first.
Time frame: Up to 24 Months
OS is defined as the time from the participant's first dose of study treatment until death from any cause.
AbbVie
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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