Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Change from baseline in QT-interval corrected (QTcF) centrally assessed	Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
Secondary	Electrocardiogram (ECG) parameter: heart rate (HR)	Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)	To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as heart rate (HR).
Secondary	ECG parameter: QT interval	Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)	To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval.
Secondary	ECG parameter: QT interval corrected according to the Bazett's formula (QTcB)	Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)	To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval corrected according to the Bazett's formula (QTcB).
Secondary	ECG parameter: QRS interval	Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)	To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QRS interval.
Secondary	ECG parameter: PR interval	Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)	To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as PR interval.
Secondary	Maximum concentration observed (Cmax)	Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks)
Secondary	Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)	Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks)
Secondary	Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities	From the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks	Assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Secondary	Overall response rate (ORR)	Up to approximately 30 weeks	The ORR, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as the best overall response as determined by investigator/local radiologist review per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria
Secondary	Duration of response (DOR)	Up to approximately 30 weeks	The DOR, defined as the time from the first documented evidence of confirmed complete response (CR) or partial response (PR) until progressive disease (PD) as determined by investigator/local radiologist review per RECIST v1.1 criteria or death (due to any cause), whichever comes first

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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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