A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Telisotuzumab Adizutecan: Intravenous (IV) Infusion

Study 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 change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC).

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries.

Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants with Adverse Events (AE)s — Up to a Maximum of 4 Years
  An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.
• Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator — Up to a Maximum of 4 Years
  Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.
• Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator — Up to a Maximum of 4 Years
  Percentage of participants with clinically significant ECGs findings as assessed by the investigator.
• Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator — Up to a Maximum of 4 Years
  Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
• Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) — Up to a Maximum of 4 Years
  OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
• Overall Survival (OS) — Up to a Maximum of 4 Years
  OS is defined as the time from randomization to the event of death from any cause.

Trial sites (51)

+ 11 more sites — see the full list on the official registry below.