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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

NCT03871348 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Metastatic Neoplasm

Interventions

DRUG

SAR441000

Pharmaceutical form: concentrate for solution for injection Route of administration: intratumoral

DRUG

Cemiplimab REGN2810

Pharmaceutical form: solution for injection Route of administration: intravenous

Sponsors & Collaborators

  • BioNTech RNA Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2022-07-25
Completion
2024-02-21
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03871348 on ClinicalTrials.gov