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Tusamitamab Ravtansine in Patients With CEACAM5-positive Advanced Solid Tumors (CARMEN-BT01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659603
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

-To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and metastatic pancreatic adenocarcinoma (mPAC)

Secondary Objective:

  • To assess the safety and tolerability of tusamitamab ravtansine
  • To assess other efficacy parameters of tusamitamab ravtansine
  • To assess the immunogenicity of tusamitamab ravtansine

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Pancreatic Carcinoma Metastatic Drug: tusamitamab ravtansine Phase 2

Detailed Description:
The expected duration of study intervention for participants may vary, based on progression date and the cohort; median expected duration of study per participant is estimated at 8 months for the mBC cohorts and 6 months for the mPAC cohort (up to 1 month for screening, a median of 4 or 2 months for treatment in the mBC and mPAC cohorts respectively, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) in Patients With CEACAM5-positive Advanced Solid Tumors
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : January 13, 2025
Estimated Study Completion Date : January 13, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A metastatic breast cancer (mBC)
tusamitamab ravtansine (SAR408701) dose administered via intravenous infusion (IV)
Drug: tusamitamab ravtansine

Pharmaceutical form: Concentrated solution for IV

Route of administration: IV infusion

Other Name: SAR408701

Experimental: Cohort B metastatic pancreatic adenocarcinoma (mPAC)
tusamitamab ravtansine (SAR408701) dose administered via intravenous infusion (IV )
Drug: tusamitamab ravtansine

Pharmaceutical form: Concentrated solution for IV

Route of administration: IV infusion

Other Name: SAR408701




Primary Outcome Measures :
  1. Objective Response Rate (ORR) of tusamitamab ravtansine (SAR408701) in participants who have confirmed complete response [ Time Frame: Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments ]
    Objective Response Rate (ORR) of tusamitamab ravtansine (SAR408701), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: Baseline up to 90 days after the last study treatment administration ]
    TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE v5.0

  2. Progression free survival (PFS) [ Time Frame: Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments ]
    PFS defined as the time from the date of first tusamitamab ravtansine (SAR408701) administration to the date of the first documented disease progression or death due to anycause, whichever comes first

  3. Disease control rate (DCR) [ Time Frame: Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments ]
    DCR defined as the percentage of participants who have achieved CR, PR or stable disease as per RECIST v1.1

  4. Duration of Response (DOR) [ Time Frame: Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments ]
    DOR defined as the time from first documented evidence of CR or PR until progressive disease determined per RECIST v1.1 or death from any cause, whichever occurs first

  5. Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine (SAR408701) [ Time Frame: Baseline until one month after last patient last treatment ]
    Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine (SAR408701)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Participant must be at least 18 years of age
  • 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).
  • Participants with ECOG performance status 0 to 1.
  • Evidence of metastatic disease.
  • Expression of CEACAM 5 by centrally assessed IHC assay

Cohort A

  • Histological or cytologic diagnosis of breast cancer.
  • Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic setting

Cohort B

  • Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
  • Have documented radiographic progression or documented intolerance after at least 1 prior systemic chemotherapy line which included either gemcitabine (or relapsed within 6 months of completion of gemcitabine adjuvant therapy) or a 5-fluorouracil based regimen (including capecitabine) but no more than 2 prior chemotherapy lines for locally advanced/metastatic disease.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent

Exclusion criteria:

  • Medical condition requiring concomitant administration of a medication with a narrow therapeutic window, that is metabolized by cytochrome P450 (CYP450), and for which a dose reduction cannot be considered.
  • Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before the first administration of study intervention.
  • Life expectancy less than 3 months.
  • Untreated brain metastases or history of leptomeningeal disease.
  • Significant concomitant illness
  • History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
  • History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or active hepatitis A, B or C infection.
  • Non-resolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy (HRT).
  • Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy.
  • Use of contact lenses. Participants using contact lenses who are not willing to stop wearing them for the duration of the study intervention are excluded.
  • Concurrent treatment with any other anticancer therapy.
  • Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for prior antitumor therapy (chemotherapy, targeted agents, immunotherapy and radiotherapy, or any investigational treatment).
  • Any prior therapy targeting CEACAM5.
  • Prior maytansinoid DM4 treatment (ADC).
  • Any major surgery within the preceding 2 weeks of the first study intervention administration.
  • Previous enrollment in this study or current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
  • Poor renal function
  • Poor hepatic function
  • Poor bone marrow function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659603


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04659603    
Other Study ID Numbers: ACT16432
2020-003096-18 ( EudraCT Number )
U1111-1244-1644 ( Registry Identifier: ICTRP )
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 14, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Maytansine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action