SAR408701 in Patients With CEACAM5-positive Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary 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

• To assess other efficacy parameters of SAR408701

• To assess the immunogenicity of SAR408701

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Diphenhydramine; Promethazine

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 toCTCAE 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.