Trial · NCT07134153
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 | Phase I Stage Cohort A: Maximum Tolerated Dose (MTD) | Up to 21 days after the first dose | Cohort A: Maximum Tolerated Dose (MTD) of intracapsular administration，In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD. |
| Primary | Phase I Stage Cohort B: Maximum serum concentration (Cmax) | Up to 21 days after the first dose | Cohort B: Maximum serum concentration (Cmax) of T-DXd in cerebrospinal fluid and blood will be investigated. |
| Primary | Phase I Stage Cohort B:Time to maximum serum concentration (Tmax) | Up to 21 days after the first dose | Cohort B: Time to maximum serum concentration (Tmax) of T-DXd in cerebrospinal fluid and blood will be investigated. |
| Primary | Phase I Stage Cohort B:Half-life (T1/2) | Up to 21 days after the first dose | Cohort B: Half-life (T1/2) of T-DXd in cerebrospinal fluid and blood will be investigated. |
| Primary | Phase II Stage Cohorts A: LM-OS | 18 months | Cohorts A: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts B: LM-OS | 18 months | Cohorts B: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts C: LM-ORR | 18 months | Cohorts C: leptomeningeal metastasis-Objective Response Rate（LM-ORR） |
| Primary | Phase II Stage Cohorts D: LM-ORR | 18 months | Cohorts D: leptomeningeal metastasis-Objective Response Rate（LM-ORR） |
| Primary | Phase II Stage Cohorts E: LM-OS | 18 months | Cohorts E: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts F: LM-OS | 18 months | Cohorts F: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts G: LM-ORR | 18 months | Cohorts G: leptomeningeal metastasis-Objective Response Rate（LM-ORR） |
| Primary | Phase II Stage Cohorts H: LM-ORR | 18 months | Cohorts H: leptomeningeal metastasis-Objective Response Rate（LM-ORR） |
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/NCT07134153/registered