Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Study ID: NCT03871348
Conditions
Study Description
Brief Summary: 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 (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 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.
Detailed Description: The expected duration of treatment for patients who benefit from study intervention may vary, based on progression date. Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy. The maximum treatment duration for non-progressive patients is up to 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute Site Number : 8400003, Boston, Massachusetts, United States
Cleveland Clinic Foundation Site Number : 8400007, Cleveland, Ohio, United States
~University of Texas - MD Anderson Cancer Center Site Number : 8400002, Houston, Texas, United States
Investigational Site Number : 0560003, Gent, , Belgium
Investigational Site Number : 0560002, Leuven, , Belgium
Investigational Site Number : 0560001, Sint-Lambrechts-Woluwe, , Belgium
Investigational Site Number : 2500004, Marseille, , France
Investigational Site Number : 2500002, Paris, , France
Investigational Site Number : 2500001, Villejuif, , France
Investigational Site Number : 2760005, Hamburg, , Germany
Investigational Site Number : 2760004, Heidelberg, , Germany
Investigational Site Number : 2760001, Mainz, , Germany
Investigational Site Number : 2760003, Mannheim, , Germany
Investigational Site Number : 2760006, Tübingen, , Germany
Investigational Site Number : 5280002, Nijmegen, , Netherlands
Investigational Site Number : 5280001, Rotterdam, , Netherlands
Investigational Site Number : 7240004, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001, Pamplona, Navarra, Spain
Investigational Site Number : 7240005, Pamplona, Navarra, Spain
Investigational Site Number : 7240002, Valencia, , Spain
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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