Breast Cancer Clinical Trial

Tusamitamab Ravtansine in Patients With CEACAM5-positive Advanced Solid Tumors

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

View Full Description

Full 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).

View Eligibility Criteria

Eligibility 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 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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT04659603

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 30 Locations for this study

See Locations Near You

AdventHealth Orlando-Site Number:8400001
Orlando Florida, 32804, United States
Massachusetts General Hospital-Site Number:8400002
Boston Massachusetts, 02114, United States
University of Wisconsin-Site Number:8400004
Madison Wisconsin, 53792, United States
Investigational Site Number :0320003
Capital Federal Buenos Aires, 1012, Argentina
Investigational Site Number :0320001
Pergamino Buenos Aires, B2700, Argentina
Investigational Site Number :0320002
Rosario Santa Fe, 2000, Argentina
Investigational Site Number :1520003
Santiago Reg Metropolitana De Santiago, 75009, Chile
Investigational Site Number :1520001
Santiago Reg Metropolitana De Santiago, 84203, Chile
Investigational Site Number :1520002
Temuco , 48105, Chile
Investigational Site Number :3480003
Budapest , 1122, Hungary
Investigational Site Number :3480002
Debrecen , 4032, Hungary
Investigational Site Number :4100003
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Investigational Site Number :4100001
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Investigational Site Number :4100002
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Investigational Site Number :5280002
Amsterdam , 1066 , Netherlands
Investigational Site Number :5280001
Rotterdam , 3015 , Netherlands
Investigational Site Number :5280003
Utrecht , 3584 , Netherlands
Investigational Site Number :6430001
Moscow , 11547, Russian Federation
Investigational Site Number :6430004
Pushkin, Saint- Petersburg , 19660, Russian Federation
Investigational Site Number :6430002
Saint -Petersburg , 19775, Russian Federation
Investigational Site Number :6430005
Saint-Petersburg , 19711, Russian Federation
Investigational Site Number :7240001
Barcelona Barcelona [Barcelona], 08035, Spain
Investigational Site Number :7240003
Madrid Madrid, Comunidad De, 28046, Spain
Investigational Site Number :7240002
Majadahonda Madrid, 28222, Spain
Investigational Site Number :1580001
Taichung , 40447, Taiwan
Investigational Site Number :1580002
Tainan , 704, Taiwan
Investigational Site Number :1580003
Taipei , 11217, Taiwan
Investigational Site Number :7920003
Adana , 01250, Turkey
Investigational Site Number :7920004
Ankara , 06100, Turkey
Investigational Site Number :7920001
Istanbul , 34722, Turkey
Investigational Site Number :7920002
Izmir , , Turkey

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT04659603

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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