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NCT04659603 · ClinicalTrials.gov registry record · Phase 2
Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT04659603 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 50 participants.
The verdict
NCT04659603, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Primary Objective: * For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) * For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: * To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine * To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine * To assess the immunogenicity of tusamitamab ravtansine * To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination
Interventions
- DRUG Gemcitabine
- DRUG tusamitamab ravtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2025-01-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04659603
The ClinicalTrials.gov registry entry for NCT04659603 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT04659603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04659603 about?
NCT04659603 is a clinical study titled "Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors". Primary Objective: * For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) * For Cohort C Par...
What is the current status of trial NCT04659603?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-03-29. Estimated completion is 2025-01-19.
What interventions are being tested in trial NCT04659603?
The interventions under investigation include: Gemcitabine (DRUG), tusamitamab ravtansine (DRUG).
Who is sponsoring clinical trial NCT04659603?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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