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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Intravenous (IV) Infusion
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 College of Medicine - Zhejiang University /ID# 263094
Hangzhou, Zhejiang, China
Dose-Limiting Toxicity (DLT) of Telisotuzumab Adizutecan in Stage 1
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
Maximum observed plasma or serum concentration (Cmax) of Telisotuzumab Adizutecan Conjugate
Cmax of telisotuzumab adizutecan conjugate.
Time frame: Up to 24 Months
Time to Cmax (Tmax) of Telisotuzumab Adizutecan Conjugate
Tmax of telisotuzumab adizutecan conjugate.
Time frame: Up to 24 Months
Area Under the Concentration-Time Curve (AUC) of Telisotuzumab Adizutecan Conjugate
AUC of telisotuzumab adizutecan conjugate.
Time frame: Up to 24 Months
Total Antibody of Telisotuzumab Adizutecan
Total antibody of telisotuzumab adizutecan.
Time frame: Up to 24 Months
Unconjugated Payload of Telisotuzumab Adizutecan
Unconjugated payload of telisotuzumab adizutecan.
Time frame: Up to 24 Months
Objective Response (OR)
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
Duration of Response (DoR)
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
Best Overall Response (BOR)
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
Progression-Free Survival (PFS)
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
Overall Survival (OS)
OS is defined as the time from the participant's first dose of study treatment until death from any cause.
Time frame: Up to 24 Months
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