Trial · NCT04466891
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Up to 34 months | Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions. |
| Secondary | Duration of Response (DOR) by ICR | Up to 45 months | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause |
| Secondary | DOR ≥ 16 Weeks by ICR | 24 weeks, up to 45 months | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 |
| Secondary | Disease Control Rate (DCR) by ICR | Up to 45 months | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 |
| Secondary | Progression-free Survival (PFS) by ICR | Up to 45 months | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause |
| Secondary | ORR by Investigator Assessment | Up to 45 months | Number of subjects who achieved a confirmed BOR of either CR or PR during treatment per RECIST 1.1 |
| Secondary | DOR by Investigator Assessment | Up to 45 months | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause |
| Secondary | DOR ≥ 16 Weeks by Investigator Assessment | 24 weeks, up to 45 months | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 |
| Secondary | DCR by Investigator Assessment | Up to 45 months | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 |
| Secondary | PFS by Investigator Assessment | Up to 45 months | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause |
| Secondary | Overall Survival | Up to 45 months | The time from the first dose of study treatment until the date of death from any cause |
| Secondary | Incidence of Adverse Events (AEs) | Up to 45 months | Number of subjects who experienced AEs or serious adverse events |
| Secondary | Incidence of Laboratory Abnormalities | Up to 45 months | Number of subjects who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 |
| Secondary | Maximum Serum Concentration of ZW25 | Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose | |
| Secondary | Trough Concentration of ZW25 | Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose | Minimum observed serum concentration (trough) |
| Secondary | Incidence of Anti-drug Antibodies (ADAs) | Up to 45 months | Number of subjects who develop ADAs |
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/NCT04466891/registered