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Chemotherapy

Tusamitamab Ravtansine + Gemcitabine for Breast Cancer (CARMEN-BT01 Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytologic diagnosis of breast cancer for Cohort A: mBC
Have confirmed diagnosis of pancreatic ductal adenocarcinoma for Cohorts B and C: mPAC
Must not have
Poor bone marrow function
Concurrent treatment with any other anti cancer therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until one month after last patient last treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effectiveness and safety of tusamitamab ravtansine in treating patients with metastatic breast cancer or metastatic pancreatic adenocarcinoma.

Who is the study for?
Adults with specific advanced solid tumors expressing CEACAM5, such as metastatic breast or pancreatic cancer. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and agree to use contraception. Excluded are those with certain eye disorders, recent major surgery, poor organ function, other active cancers or infections like HIV/AIDS and hepatitis, untreated brain metastases, or prior treatments targeting CEACAM5.
What is being tested?
The trial is testing tusamitamab ravtansine alone and combined with gemcitabine for effectiveness against certain cancers. It aims to confirm the best dose of tusamitamab ravtansine when used with gemcitabine and evaluate safety, tolerability, immune response generation (immunogenicity), and how the body processes these drugs (pharmacokinetics).
What are the potential side effects?
Potential side effects include reactions at the infusion site where the drug enters the body through a vein; general feelings of discomfort; issues affecting organs like kidneys or liver due to toxicity; possible blood-related problems; increased risk of infection; and possibly unique side effects related to tusamitamab ravtansine's mechanism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with metastatic breast cancer.
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I have been diagnosed with pancreatic cancer.
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My cancer cells show CEACAM 5 presence.
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My cancer progressed after 1-2 chemo treatments including gemcitabine or 5-FU.
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I've had 1-4 chemotherapy treatments for metastatic breast cancer, depending on its type.
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I am 18 years old or older.
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I can carry out all my usual activities without help.
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My cancer has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bone marrow does not work well.
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I am not currently receiving any other cancer treatments.
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I have had treatment targeting CEACAM5 before.
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I have brain metastases that haven't been treated or a history of leptomeningeal disease.
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I do not have AIDS, HIV requiring treatment, or active hepatitis A, B, or C.
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My liver isn't working well.
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My kidneys are not working well.
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I have previously been treated with a drug called maytansinoid DM4.
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I have not had major surgery in the last 2 weeks.
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I have a corneal disorder that could worsen with certain medications.
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I need a specific medication that cannot be adjusted and is sensitive to how my body processes drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until one month after last patient last treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until one month after last patient last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of dose-limiting toxicites (DLTs)- Cohort C Part 1
Objective Response Rate (ORR)- Cohort A, Cohort B, and Cohort C Part 2
Secondary study objectives
Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)
Disease control rate (DCR)
Duration of Response (DOR)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C Metastatic pancreatic adenocarcinoma (mPAC)Experimental Treatment2 Interventions
tusamitamab ravtansine every 2 weeks combined with gemcitabine on Day 1, Day 8 and Day 15 every 4 weeks administered via intravenous infusion (IV)
Group II: Cohort B metastatic pancreatic adenocarcinoma (mPAC)Experimental Treatment1 Intervention
tusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV)
Group III: Cohort A metastatic breast cancer (mBC)Experimental Treatment1 Intervention
tusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,197 Previous Clinical Trials
4,034,828 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
871 Previous Clinical Trials
2,020,333 Total Patients Enrolled

Media Library

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04659603 — Phase 2
Pancreatic Endocrine Carcinoma Research Study Groups: Cohort A metastatic breast cancer (mBC), Cohort B metastatic pancreatic adenocarcinoma (mPAC), Cohort C Metastatic pancreatic adenocarcinoma (mPAC)
Pancreatic Endocrine Carcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04659603 — Phase 2
Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04659603 — Phase 2
~11 spots leftby Nov 2025
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