Trial · NCT05703555
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | intratumoral DM4 concentration | approximately 5 weeks, more specific day 3 of cycle 2 (each cycle is 14 days) | Intratumoral DM4 exposure, as measured in a biopsied lesion using a PK assay. |
| Secondary | Intratumoral tusamitamab ravtansine concentration | approximately 5 weeks, more specific day 3 of cycle 2 (each cycle is 14 days) | Intratumoral concentrations of Tusamitamab ravtansine and metabolites of DM4: Lys-SPDB-DM4, Me-DM4 using a PK assay |
| Secondary | Incidence of grade 3 or 4 adverse events | during treatment (up to 2 years and 12 weeks) | Incidence of grade 3 or 4 adverse events as assessed by CTCAE version 5.0 |
| Secondary | Response to treatment | every 8 weeks during treatment (up to 2 years and 12 weeks) | Number of participants with either progressive disease, stable disease, partial response or complete response according to RECIST v 1.1 |
| Secondary | CEACAM5 expression | approximately 5 weeks, more specific day 3 of cycle 2 (each cycle is 14 days) | Change in CEACAM5 expression from baseline as assessed by immunohistochemistry |
| Secondary | RNA expression levels | approximately 5 weeks, more specific day 3 of cycle 2 (each cycle is 14 days) | Change from baseline in RNA expression levels as assessed with differential gene-level analysis in DESeq2 |
| Secondary | circulating CEA levels | every 8 weeks during treatment (up to 2 years and 12 weeks) | Number of patients with elevated levels of circulation CEA |
| Secondary | tumor genomic features | baseline | Somatic copy number, strucural and nucleotide alterations as assessed by whole genome sequencing |
| Secondary | Maximal plasma concentration | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | Cmax and its corresponding time (Tmax) |
| Secondary | AUCinf | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | AUCinf - Area under the curve form time of dosing extrapolated to infinity of AUC0-t + Clast/lambda z |
| Secondary | AUClast | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | AUClast - Area under the curve form the time of dosing to the time of the last quantifiable concentration calculated using the linear trapezoidal rule |
| Secondary | AUCt | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | AUCt - Area under the concentration versus time curve |
| Secondary | Thalf | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | Thalf will be calculated as ln(2)/Lambda z |
| Secondary | systemic tusamitamab ravtansine concentration | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | Clearance (Cl) |
| Secondary | Volume of distribution | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | Volume of distribution |
| Secondary | concentration DM4 metabolites: Lys-SPDB-DM4, Me-Dm4 | baseline and at 7 different time points during treatment (3x cycle 1 day 1, 1x pre-dose cycle 2 day 1, 2x cycle 2 day 2, and 1x pre-dose cycle 4 day 1) (each cycle is 14 days) | concentration of metabolites of DM4 will be described |
| Secondary | features in tumor micro-environment | approximately 5 weeks, more specific day 3 of cycle 2 (each cycle is 14 days) | RNA-sequencing to deduce the immune contexture using quanTIseq, tumor infiltrating lymphocyte signatures and related workflows |
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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