A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Publication date: Mar 12, 2019

Primary Objectives: – Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. – Dose expansion (Monotherapy): To determine the objective response rate of SAR441000 administered intratumorally as monotherapy in patients with advanced melanoma whose disease has progressed after prior therapy based on anti-PD-1 or anti-PD-L1. – Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma. Secondary Objectives: – To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab. – To assess the immunogenicity of SAR441000. – To characterize the safety of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab. – To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000. – To determine the recommended dose of SAR441000 for the expansion phase.

Concepts Keywords
AIDS Transplantation
Alternative Therapy Melanoma
Autoimmune Combination therapy
Basal Sanofi
Biopsy Cemiplimab
Blood Lung cancer
Bone Marrow RTT
Brain Cancer research
Carcinoma Clinical medicine
Cervix Medicine
Coagulation Cancer
Cohort Contraceptive methods
Combination Therapy Mandatory tumor
Contraceptive Combination cemiplimab melanoma
Cooperative Group HIV
DoR Tumors
Hepatitis Cervix local tumors
HIV AIDS
Immune Suppression Unresolved viral hepatitis
Immunodeficiency Alternative therapy
Immunogenicity Antiretroviral treatment
Immunosuppressive
Informed Consent
Kidney
Lesion
Liver
Malignancy
Malignant Tumor
Maximum Tolerated Dose
Median
Melanoma
Metastasis
Monotherapy
Neoplasm
Organ
Pharmacokinetic
Prednisolone
Progressive
Sanofi
Splenectomy
Squamous Carcinoma
Squamous Cell
Tolerability
Toxicity
Tumor
Virus

Semantics

Type Source Name
disease MESH Neoplasm Metastasis
drug DRUGBANK Prednisolone
disease DOID autoimmune disease
disease MESH Squamous Cell Cancer
gene UNIPROT TP53INP2
disease DOID malignant tumor
gene UNIPROT OPRD1
gene UNIPROT DCXR
disease DOID head and neck squamous cell carcinoma
disease DOID squamous cell carcinoma
gene UNIPROT CD274
disease MESH squamous cell carcinoma
gene UNIPROT PDCD1
gene UNIPROT RPL17
pathway BSID Melanoma
disease MESH melanoma
disease DOID melanoma
gene UNIPROT MXD1
gene UNIPROT AMPD1
disease MESH Tumors
gene UNIPROT MT1E
disease MESH autoimmune disease
disease MESH acquired immunodeficiency syndrome
disease DOID acquired immunodeficiency syndrome
disease DOID viral hepatitis
disease DOID carcinoma
disease DOID skin cancer
disease MESH carcinoma
disease MESH skin cancer

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