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SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors

Pharmaceutical form: solution for infusion

Route of administration: intravenous

SAR408701

Pharmaceutical form: solution for eye drop

Route of administration: eye drop

dexamethasone

naphazoline

Pharmaceutical form: tablet

Route of administration: oral

diphenhydramine

Clinical Sciences & Operations

Primary Objective:

* To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors.

Secondary Objectives:

* To characterize the overall safety profile of SAR408701 monotherapy.
* To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites.
* To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part.
* To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity.
* To assess the potential immunogenicity of SAR408701.

The study duration per participant will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an End-of-Treatment (EOT) visit around 30 days after the last administration of IMP, and at least one follow-up (FU) visit after the EOT visit.

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors

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

IMP-related DLTs are defined as adverse events (AE) related to the IMPs in absence of clear evidence to the contrary, after validation by the Study Committee, and if not related to a disease progression, graded using National Cancer Institute common Toxicity Criteria (NCI-CTC) scale v4.03

Overall safety profile characterized in terms of the type, frequency, severity, seriousness, and relationship to study therapy of any AEs based on standard and systematic assessment including physical findings, laboratory tests or other investigations

Cmax for SAR408701 will be assessed after single and repeat doses, as relevant

Cmax for DM4 and Me-DM4 will be assessed after single and repeat doses, as relevant

Tmax for SAR408701 will be assessed after single and repeat doses, as relevant

Tmax for DM4 and Me-DM4 will be assessed after single and repeat doses, as relevant

AUC of SAR408701 from time zero extrapolated to infinity

AUC of DM4 and Me-DM4 from time zero extrapolated to infinity

Assessment of plasma CEACAM5 levels in main dose-escalation part

Assessment of tumor response using standard imaging, as defined by RECIST 1.1 criteria

Immunogenicity evaluation for anti-SAR408701 antibodies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors	NCT03324113	Neoplasm Malign...	SAR408701 dexamethasone naphazoline diphenhydramine	20 Years -	Sanofi
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors	NCT03324113	Neoplasm Malign...	SAR408701 dexamethasone naphazoline diphenhydramine	20 Years -	Sanofi

Spots Global Cancer Trial Database for naphazoline

Every month we try and update this database with for naphazoline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for naphazoline

Every month we try and update this database with for naphazoline cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for naphazoline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.