Pure Global
NCT05450562

Dose Escalation and Expansion Study of SAR444200 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.
Sanofi·Phase 1/2·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Neoplasm
Drug/Device/Intervention
SAR444200
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Sanofi
Location
Quebec,Seoul, Canada,South Korea
Timeline & enrollment
Phase
Phase 1/2
Start date
Sep 29, 2022
End date
May 11, 2029
Enrollment
106 participants
Primary outcome

Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs),Part 1A and 1B: Number of participants with Adverse Events (AEs),Part 2A: Objective Response Rate (ORR)

Summary

This is a single group, treatment, Phase 1/Phase 2, open label, multiple cohort,
 first-in-human study to evaluate safety 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.

ICD-10 classifications
NeoplasmsBenign neoplasmsIn situ neoplasmsPersonal history of other neoplasmsBenign neoplasm: Other specified sites
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05450562
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05450562 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Sanofi and is currently Recruiting. The study focuses on Neoplasm. Target enrollment is 106 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.