Registered outcomes14

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

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)	During Cycle 1 (cycle length = 21 days)	DLTs are defined as the events pre-specified in the protocol and which are not clearly due to the underlying disease or extraneous causes. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Primary	Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to approximately 2.9 years	An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the start date of trial intervention to 35 days \[28 (+7) days\] after the last dose date of trial intervention).
Primary	Phase 2: Objective Response Rate (ORR) as Assessed by Investigator	Up to approximately 2.9 years	Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by the investigator per RECIST v1.1.
Secondary	Phase 1: ORR as Assessed by Investigator	Up to approximately 2.9 years	ORR is defined as the percentage of participants with a BOR of confirmed CR or confirmed PR, as assessed by the investigator per RECIST v1.1.
Secondary	Phase 2: Number of Participants With TEAEs	Up to approximately 2.9 years	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the start date of trial intervention to 35 days \[28 (+7) days\] after the last dose date of trial intervention).
Secondary	Phase 1 and 2: Duration of Response (DoR) as Assessed by the Investigator	Up to approximately 2.9 years	DoR is defined as the time (in months) from the date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression or death due to any cause.
Secondary	Phase 1 and 2: Clinical Benefit Rate (CBR) as Assessed by the Investigator	Up to approximately 2.9 years	CBR is defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) lasting ≥183 days, as assessed by the investigator per RECIST v1.1.
Secondary	Phase 1 and 2: Disease Control Rate (DCR) as Assessed by the Investigator	Up to approximately 2.9 years	DCR is defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD as assessed by the investigator per RECIST v1.1.
Secondary	Phase 1 and 2: Time to Response (TTR) as Assessed by the Investigator	Up to approximately 2.9 years	TTR is defined as the time (in months) from the start date of trial intervention (randomization for randomized cohort) to the date of the first documentation of objective response in responders (BOR of confirmed CR or confirmed PR as assessed by the investigator per RECIST v1.1).
Secondary	Phase 1 and 2: Best Percentage Change in the SoD of Measurable Tumors as Assessed by Investigator	Up to approximately 2.9 years	The best percentage change in SoD as assessed by the investigator per RECIST v1.1, defined as the percentage change in the smallest SoD from all postbaseline tumor assessments, taking as reference the baseline SoD.
Secondary	Phase 1 and 2: Progression-free Survival (PFS) as Assessed by the Investigator	Up to approximately 2.9 years	PFS is defined as the time (in months) from the start date of trial intervention (randomization for randomized cohort) to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause.
Secondary	Phase 1 and 2: Overall Survival (OS)	Up to approximately 2.9 years	OS is defined as the time (in months) from the start date of trial intervention (date of randomization for randomized cohort) to the date of death due to any cause.
Secondary	Phase 1 and 2: Plasma Concentration of Dato-DXd, Total Anti-TROP2 Antibody and MAAA-1181a	Pre-dose and at multiple timepoints post-dose from Cycle 1 up to Cycle 8 (each cycle=21 days)
Secondary	Phase 1 and 2: Percentage of Participants With Positive Anti-drug Antibodies (ADAs)	Up to approximately 2.9 years

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.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT07890714/registered

API reference For AI assistants