Trial · NCT05703555
INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
NCT05703555, Phase 2, Withdrawn, Erasmus Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701. Trials, record NCT05703555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05703555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
- NCT number
- NCT05703555
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Erasmus Medical Center
- Conditions
- Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer
- Interventions
- Tusamitamab ravtansine
- First posted
- 2023-01-30
- Last updated
- 2024-02-28
- Other registries' IDs
- eudract:2022-003451-34
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05703555
GET https://conductscience.org/api/trials/v1/NCT05703555/registered