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

  • STATUS
    Not Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    231
  • sponsor
    Sanofi
Updated on 7 July 2022
cancer
lymphoma
measurable disease
carcinoma
pd-l1
solid neoplasm
squamous cell carcinoma of head and neck

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.

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.

Details
Condition Metastatic Neoplasm
Treatment Cemiplimab REGN2810, SAR441000
Clinical Study IdentifierNCT03871348
SponsorSanofi
Last Modified on7 July 2022

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