NCT04913220

A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: * To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab * To assess other indicators of antitumor activity * To assess the concentrations of SAR444245 when given in combination with cemiplimab * To assess the immunogenicity of SAR444245 * To assess active concentrations of cemiplimab when given in combination with SAR444245

Detailed description

The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period \[max 35 cycles or until PD\], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier

Conditions

• Malignant Melanoma
• Squamous Cell Carcinoma of Skin

Interventions

Type	Name	Description
DRUG	THOR-707	Solution for infusion: intravenous infusion
DRUG	Cemiplimab	Solution for infusion: intravenous infusion

Timeline

• Start date: 2021-07-15
• Primary completion: 2023-08-22
• Completion: 2025-02-18
• First posted: 2021-06-04
• Last updated: 2026-02-04
• Results posted: 2026-02-04

Locations

24 sites across 7 countries: United States, Australia, Chile, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study