Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	Progression Free Survival (PFS) as Assessed by BICR	Up to a Maximum of 4 Years	PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.
Secondary	OS	Up to a Maximum of 4 Years	OS is defined as the time from randomization to the event of death from any cause
Secondary	Duration of Response (DOR) as Assessed by BICR	Up to a Maximum of 4 Years	DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by BICR or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
Secondary	Disease Control (DC) as Assessed by BICR	Up to a Maximum of 4 Years	DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by BICR.
Secondary	OR as Assessed by Investigator	Up to a Maximum of 4 Years	OR is defined as confirmed CR or confirmed PR as assessed by investigator per RECIST, version 1.1.
Secondary	PFS as Assessed by Investigator	Up to a Maximum of 4 Years	PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.
Secondary	DOR as Assessed by Investigator	Up to a Maximum of 4 Years	DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by BICR or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
Secondary	Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Maximum observed serum (or plasma, for payload) concentration for telisotuzumab adizutecan.
Secondary	Time to Cmax (Tmax) for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Time to Cmax for telisotuzumab adizutecan.
Secondary	Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Terminal elimination half-life for telisotuzumab adizutecan.
Secondary	Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Area under the serum (or plasma, for payload) concentration versus time curve will be determined using noncompartmental methods for total antibody for telisotuzumab adizutecan.
Secondary	Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Antibody drug conjugate for telisotuzumab adizutecan.
Secondary	Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Unconjugated Top1 inhibitor payload for telisotuzumab adizutecan.
Secondary	Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan	Up to a Maximum of 4 Years	Incidence of anti-drug antibodies for telisotuzumab adizutecan.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Registered outcomes21

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