Trial · NCT05622890
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 2 years | Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the BIRC. |
| Secondary | Duration of response (DOR) | Up to 2 years | The time interval from initial response (CR or PR) assessed by the investigator and the BIRC to progressive disease (PD) assessed by the BIRC |
| Secondary | ORR assessed by the investigator | Up to 2 years | The best response of CR or PR assessed by the investigator. |
| Secondary | DOR assessed by the investigator | Up to 2 years | The time interval from initial response (CR or PR) assessed by the investigator to PD assessed by the investigator |
| Secondary | Treatment-emergent adverse events (TEAEs) and Laboratory results,physical examinations, or vital signs | Up to 2 years | Adverse Events (AE's) will be evaluated according to the NCI CTCAE v5.0. AE's will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT). |
| Secondary | Determination of CA-125 response with GCIG criteria | Up to 2 years | GCIG CA-125 response rate will be calculated using the CA-125 Response-Evaluable population and its exact 95% CI will be estimated using the Clopper-Pearson method. |
| Secondary | PFS assessed by the BIRC | Up to 2 years | The time interval from the first dose of IMGN853 to radiographic PD or death assessed by the BIRC, whichever occurs first. |
| Secondary | PFS assessed by the investigator | Up to 2 years | The time interval from the first dose of IMGN853 to radiographic PD or death assessed by the investigator, whichever occurs first. |
| Secondary | Overall survival (OS) | Up to 2 years | The time interval from the first dose of IMGN853 to death |
| Secondary | Summary statistics of intact ADC, total Ab (TAb), DM4 and S-methyl DM4 concentration data over time | Up to 2 years | To assess the PK properties of IMGN853 and its key metabolites |
| Secondary | Incidence of seroconversion of ADA caused by IMGN853 and its relationship to safety and efficacy | Up to 2 years | Subjects will be evaluated for anti-drug antibody (ADA) levels. Confirmatory experiments will be conducted for positive samples. ADA titers and neutralizing antibodies (Nabs) will be further determined as appropriate after the confirmation of positivity. |
| Other | Relationship between test results using the companion diagnostic reagent from MEDx Translational Medicine (Suzhou) Co., Ltd. and efficacy of IMGN853 and consistency with VENTANA FOLR1 | Up to 2 years | Samples will be tested by another CDx at same time to certify the consistency with VENTANA FOLR1 |
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/NCT05622890/registered