Trial · NCT03045393
Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC
NCT03045393, Phase 1, Withdrawn, Duke University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC. Trials, record NCT03045393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03045393
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC
- NCT number
- NCT03045393
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Breast Cancer Triple Negative
- Interventions
- Mirvetuximab Soravtansine (IMGN853)
- First posted
- 2017-02-07
- Last updated
- 2018-07-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine | Baseline up to 9 weeks | Assessed by immunohistochemistry (IHC) (1) after completion of neoadjuvant chemotherapy, prior to treatment with mirvetuximab soravtansine; (2) at definitive surgery, after treatment with mirvetuximab soravtansine and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors). |
| Secondary | Change in breast tumor FRα expression before and after neoadjuvant chemotherapy | Baseline up to 9 weeks | Assessed by immunohistochemistry (IHC) (1) at initial cancer diagnosis, prior to initiation of neoadjuvant chemotherapy; (2) after completion of neoadjuvant chemotherapy and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors). |
| Secondary | Total number of grade 3 and 4 toxicities | Baseline up to 9 weeks | Graded via NCI CTCAE v4.03 |
| Secondary | Number of treatment-emergent adverse events (TEAEs) precluding second dose | Baseline up to 9 weeks | Assessed by the number of subjects that cannot receive the second dose of mirvetuximab soravtansine |
| Secondary | Number of treatment-emergent adverse events (TEAEs) delaying surgery | Baseline up to 9 weeks | Assessed by the number of subjects that have surgery delayed past 9 weeks due to TEAE |
| Secondary | Total number of partial or complete responses | Baseline up to 9 weeks | Evaluated by the number of subjects that have either a partial or complete radiologic response by 2D ultrasound. (Partial response = reduction of the largest unidimensional tumor measurement of \>30%; Complete response = no evidence of tumor remaining) |
| Secondary | Change in tumor cell proliferation, as measured by Ki67 expression | Baseline up to 9 weeks | Changes in Ki67 expression will be measured before and after 2 doses of mirvetuximab soravtansine. |
| Secondary | Change in tumor cell death markers | Baseline up to 9 weeks | Changes in apoptotic markers will be measured before and after 2 doses of mirvetuximab soravtansine. |
Source ClinicalTrials.gov
Outcomes0
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/NCT03045393
GET https://conductscience.org/api/trials/v1/NCT03045393/registered