SAR408701 in patients with CEACAM5-positive advanced solid tumors
- Conditions
- CancerMedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10033610Term: Pancreatic carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003096-18-ES
- Lead Sponsor
- Sanofi aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
-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.
Prior/concomitant therapy
-Concurrent treatment with any other anti cancer 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.
Prior/concurrent clinical study experience
-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.
Diagnostic assessments
-Poor renal function
-Poor hepatic function
-Poor bone marrow function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To assess the antitumor activity of SAR408701 in metastatic breast cancer (mBC) and metastatic pancreatic adenocarcinoma (mPAC);Secondary Objective: •To assess the safety and tolerability of SAR408701<br>•To assess other efficacy parameters of SAR408701<br>•To assess the immunogenicity of SAR408701;Primary end point(s): Objective Response Rate (ORR) of 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;Timepoint(s) of evaluation of this end point: Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments
- Secondary Outcome Measures
Name Time Method