NCT05450562

Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Detailed description

Treatment Period: enrolled participants will receive continuous treatment until disease progression (PD), unacceptable adverse event (AE), or other permanent discontinuation criteria. The End of Treatment visit will occur 30 days ±7 days from last IMP administration or prior to initiation of further therapy, whichever occurs first.

Conditions

• Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	SAR444200	Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion
BIOLOGICAL	Atezolizumab	concentrate for solution for infusion Route of administration: intravenous (IV) infusion

Timeline

• Start date: 2022-09-20
• Primary completion: 2025-12-22
• Completion: 2025-12-22
• First posted: 2022-07-08
• Last updated: 2026-01-14

Locations

13 sites across 5 countries: United States, Canada, China, Singapore, South Korea

Regulatory

• FDA-regulated drug study