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Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors - Trial NCT05450562

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.

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NCT05450562
Phase 1/2
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT05450562
View on ClinicalTrials.gov
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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.

Study Focus

Neoplasm

SAR444200

Interventional

biological

Sponsor & Location

Sanofi

Quebec,Seoul, Canada,South Korea

Timeline & Enrollment

Phase 1/2

Sep 29, 2022

May 11, 2029

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

Neoplasms
Benign neoplasms
In situ neoplasms
Personal history of other neoplasms
Benign neoplasm: Other specified sites

Data Source

ClinicalTrials.gov

NCT05450562

Non-Device Trial