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Tusamitamab Ravtansine + Gemcitabine for Breast Cancer (CARMEN-BT01 Trial)
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.
CARMEN-BT01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCARMEN-BT01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CARMEN-BT01 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Cohort A metastatic breast cancer (mBC)
- Group 2: Cohort B metastatic pancreatic adenocarcinoma (mPAC)
- Group 3: Cohort C Metastatic pancreatic adenocarcinoma (mPAC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Does this research still need more participants?
"Yes, this is an ongoing study that was originally posted on March 29th, 2021 according to the information available on clinicaltrials.gov. The listing was last updated on November 10th, 2022."
How many people are signing up for this clinical trial?
"The sponsor, Sanofi, needs to recruit 94 eligible patients from multiple sites in order to run the study. There are locations in Boston and Madison."
What are the goals that this clinical trial is hoping to achieve?
"The primary focus of this study, which will last for 28 days (Cycle 1), is to observe the Objective Response Rate in Cohort A, Cohort B, and Cohort C Part 2. Additionally, researchers will be secondary outcomes including the Incidence of participants with ATAs against tusamitamab ravtansine as well as the Maximum concentration observed after infusion (Cmax) of tusamitamab ravtansine and Total body clearance (CL) of gemcitabine."
What are the most similar studies that have been published about SAR408701?
"Currently, there are 34 clinical trials underway for SAR408701. Of these, 9 have reached Phase 3. Some of the locations testing this experimental drug are in Birmingham, Alabama; however, 805 other research sites across the globe are also running trials."
What medical conditions has SAR408701 been known to improve?
"The medical conditions angioedema, bronchitis, and delayed hypersensitivity can all be alleviated by SAR408701."
What are some of the dangers associated with taking SAR408701?
"While there is some evidence from Phase 2 clinical trials that SAR408701 may be safe, its efficacy has not yet been explored, so it received a score of 2."
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