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.
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
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.
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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