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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Sanofi
Study ID
NCT03871348
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAR441000 — DRUG
    Pharmaceutical form: concentrate for solution for injection Route of administration: intratumoral
  • Cemiplimab REGN2810 — DRUG
    Pharmaceutical form: solution for injection Route of administration: intravenous

Study Details

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.

Key Dates

Start date
Jan 3, 2019
Status verified
Sep 2025
Primary completion
Jul 25, 2022
Completion
Feb 21, 2024

Study Design

Enrollment
77 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR441000 Dose Escalation Phase
    SAR441000 will be administered as intratumoral injection as monotherapy in patients with solid tumors over a 28-day cycle
  • Experimental: SAR441000 + cemiplimab - Dose Escalation Phase
    SAR441000 will be administered as intratumoral injection in patients with solid tumors in combination with cemiplimab over a 21-day cycle
  • Experimental: SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 failure
    SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced melanoma who have failed anti-PD-1/PD-L1 therapy. Treatment is administered over a 21-day cycle
  • Experimental: SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 naive
    SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve melanoma over a 21-day cycle
  • Experimental: SAR441000 + cemiplimab Expansion CSCC, anti-PD-1 naive
    SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Cutaneous Squamous Cell Carcinoma (CSCC) over a 21-day cycle
  • Experimental: SAR441000 + cemiplimab Expansion HNSCC, anti-PD-1 naive
    SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Head and Neck Squamous Cell Cancer (HNSCC) over a 21-day cycle

Primary Outcome Measure

For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy) [ Time Frame: Cycle 1; Cycle = 28 days for monotherapy ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer Institute- Site Number : 8400003BostonMassachusetts02215-
Cleveland Clinic - Cleveland- Site Number : 8400007ClevelandOhio44195-
The University of Texas MD Anderson Cancer Center- Site Number : 8400002HoustonTexas77030-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MACleveland Clinic - Cleveland· Cleveland, OHThe University of Texas MD Anderson Cancer Center· Houston, TX

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