metastatic breast cancer metastatic pancreatic adenocarcinoma
Conditions
Interventions
Cohort A&B: tusamitamab ravtansine (SAR408701), IV infusion, once every two
weeks.
Cohort C: Treatment per cycles each consisitng of 28 days, with tusamitamab
ravtansine (SAR408701) IV infusion foll
Sponsors
Genzyme Europe BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Participant must be at least 18 years of age. - Participants with at least one measurable lesion according to the RECIST 1.1 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 CEACAM5 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. Cohort C: - Have confirmed diagnosis of pancreatic ductal adenocarcinoma. - Have documented radiographic progression or documented intolerance after 1st line fluoropyrimidine-containing chemotherapy (or relapsed within 6 months of completion of chemotherapy as adjuvant therapy) 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
Exclusion criteria: Medical Condition - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cohort A, B and C part 2: objective Response Rate (ORR) of tusamitamab ravtansine (SAR408701) of participants who have a confirmed complete response (CR) or partial response (PR). - Cohort C part 1: Incidence of dose-limiting toxicites (DLTs) in the 28 Day DLT observation period (Cycle 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. - Progression-free survival (PFS). - Disease control rate (DCR). - Duration of response (DOR). - Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine (SAR408701). - Pharmacokinetic parameters of tusamitamab ravtansine and gemcitabine | — |
Countries
Netherlands
Outcome results
None listed