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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
Participants with at least one measurable lesion according to the RECIST v1.1 criteria that has not been irradiated (ie, newly arising lesions in previously irradiated areas are accepted)
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 below
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I have been diagnosed with metastatic breast cancer.
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I have a tumor that can be measured and hasn't been treated with radiation.
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I have been diagnosed with pancreatic cancer.
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I agree to use birth control as required by the study.
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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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My cancer worsened or I couldn't tolerate the first chemotherapy for advanced pancreatic cancer.
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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 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

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 more

CARMEN-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
2,158 Previous Clinical Trials
3,514,298 Total Patients Enrolled
52 Trials studying Breast Cancer
24,229 Patients Enrolled for Breast Cancer
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,905 Total Patients Enrolled
11 Trials studying Breast Cancer
2,117 Patients Enrolled for Breast Cancer

Media Library

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04659603 — Phase 2
Breast Cancer Research Study Groups: Cohort A metastatic breast cancer (mBC), Cohort B metastatic pancreatic adenocarcinoma (mPAC), Cohort C Metastatic pancreatic adenocarcinoma (mPAC)
Breast Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

What medical conditions has SAR408701 been known to improve?

"The medical conditions angioedema, bronchitis, and delayed hypersensitivity can all be alleviated by SAR408701."

Answered by AI

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."

Answered by AI
~0 spots leftby Apr 2024