Trial · NCT05429762
Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors
NCT05429762, Phase 1, Terminated, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors. Trials, record NCT05429762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05429762
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors
- NCT number
- NCT05429762
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 56 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Neoplasm
- Interventions
- Tusamitamab ravtansine
- First posted
- 2022-06-23
- Last updated
- 2025-04-06
- Other registries' IDs
- eudract:2022-001213-39
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in QT-interval corrected (QTcF) centrally assessed | Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks) | |
| Secondary | Electrocardiogram (ECG) parameter: heart rate (HR) | Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks) | To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as heart rate (HR). |
| Secondary | ECG parameter: QT interval | Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks) | To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval. |
| Secondary | ECG parameter: QT interval corrected according to the Bazett's formula (QTcB) | Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks) | To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval corrected according to the Bazett's formula (QTcB). |
| Secondary | ECG parameter: QRS interval | Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks) | To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QRS interval. |
| Secondary | ECG parameter: PR interval | Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks) | To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as PR interval. |
| Secondary | Maximum concentration observed (Cmax) | Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks) | |
| Secondary | Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d) | Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks) | |
| Secondary | Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities | From the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks | Assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Secondary | Overall response rate (ORR) | Up to approximately 30 weeks | The ORR, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as the best overall response as determined by investigator/local radiologist review per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT05429762
GET https://conductscience.org/api/trials/v1/NCT05429762/registered