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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until one month after last patient last treatment
Awards & highlights
CARMEN-BT01 Trial 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.Check my eligibility
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).See study design
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.
CARMEN-BT01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CARMEN-BT01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline until one month after last patient last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until one month after last patient last treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicites (DLTs)- Cohort C Part 1
Objective Response Rate (ORR)- Cohort A, Cohort B, and Cohort C Part 2
Secondary outcome measures
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 moreCARMEN-BT01 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
~2070
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,171 Previous Clinical Trials
3,517,044 Total Patients Enrolled
52 Trials studying Breast Cancer
24,229 Patients Enrolled for Breast Cancer
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
2,020,347 Total Patients Enrolled
11 Trials studying Breast Cancer
2,117 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than 3 months.You have a serious other health problem.I can stop taking strong CYP3A inhibitors 2 weeks before starting the study treatment.I have been diagnosed with metastatic breast cancer.I have a tumor that can be measured and hasn't been treated with radiation.My bone marrow does not work well.I have been diagnosed with pancreatic cancer.All my treatment side effects are mild, except for hair loss, skin color changes, or thyroid issues managed with hormones.I am not currently receiving any other cancer treatments.I agree to use birth control as required by the study.I have had treatment targeting CEACAM5 before.My cancer cells show CEACAM 5 presence.I have brain metastases that haven't been treated or a history of leptomeningeal disease.I haven't had cancer treatment in the last 3 weeks or 5 half-lives of the treatment, whichever is shorter.My cancer progressed after 1-2 chemo treatments including gemcitabine or 5-FU.I haven't had any cancer other than skin or cervical in the last 3 years, except the one being treated now.I've had 1-4 chemotherapy treatments for metastatic breast cancer, depending on its type.My cancer worsened or I couldn't tolerate the first chemotherapy for advanced pancreatic cancer.I do not have AIDS, HIV requiring treatment, or active hepatitis A, B, or C.My liver isn't working well.My kidneys are not working well.I have previously been treated with a drug called maytansinoid DM4.I am 18 years old or older.I have not had major surgery in the last 2 weeks.I have a corneal disorder that could worsen with certain medications.I need a specific medication that cannot be adjusted and is sensitive to how my body processes drugs.I can carry out all my usual activities without help.My cancer has spread to other parts of my body.I have had treatments with taxane or gemcitabine.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A metastatic breast cancer (mBC)
- Group 2: Cohort B metastatic pancreatic adenocarcinoma (mPAC)
- Group 3: Cohort C Metastatic pancreatic adenocarcinoma (mPAC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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