First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor

• Status: Completed
• Trial end date: 2017-04-07
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR566658

Secondary Objectives:

• To characterize the safety profile of SAR566658

• To evaluate the pharmacokinetic profile of SAR566658

• To assess the potential immunogenicity of SAR566658

• To assess preliminary antitumor activity

• To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam

• To assess safety in the alternative schedules of SAR566658 administration

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria:

Diagnosis of CA6-positive solid tumors as moderate to intense membrane staining of ≥15% of tumor cells for which no standard therapy is available.

Exclusion criteria:

• Eastem Cooperative Oncology Group performance status ≥2.

• Any serious active disease or co-morbid condition, which, in the opinion of the Investigator, may interfere with the safety or the compliance with the study.

• Poor bone marrow reserve.

• Poor liver and renal function.

• Pregnant or breast-feeding woman.

• No use of effective birth control methods, when applicable.

• No resolution of all specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to Grade ≤1 according to the National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade scaling.

• Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment, (and less than 6 weeks in case of prior nitroso-urea and or mitomycin C treatment). Patients will be eligible if hormonotherapy (ie, for breast tumors) is discontinued before first Investigational product administration.

• Wash out period of less than 1 week from last palliative dose of radiotherapy.

• Patients with respiratory insufficiency defined by a decrease more than 50% compared to theoretical baseline pulmonary volumes and theoretical baseline Diffusing capacity of the Lung for Carbon monoxyde.

• Any lung radiotherapy in patient's cancer history.

• Patients with previous history or active interstitial lung disease or pulmonary fibrosis.

• Patients with abnormal cardiac function defined by a Left Ventricular Ejection Fraction <50%.

• Patients with previous history of acute cardiac failure.

• Patients with previous history and/or unresolved corneal disorders.

• Known intolerance to infused protein products or maytansinoids.

• Patients treated with strong CYP3A inhibitors within 2 weeks prior study drug administration.

• For patients to be treated in the midazolam cohort:

• Any treatment known to induce CYP3A isoenzymes or to inhibit CYP3A4 activities not allowed within 2 weeks before midazolam administration and up to the end of pharmacokinetic sampling following the last midazolam administration.

• Any contra-indications to midazolam, according to the applicable labeling.

• Patients older than 60 years.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.