Cemiplimab for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Investigational Site Number :4100002, Seoul, Korea, Republic of
Cancer
Cemiplimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Baseline to end of study (up to 2 years)

Year 2
Part 1A and 1B: Objective Response Rate (ORR)
Year 2
All parts: Duration of response (DoR)
Day 21
All parts: Assessment of PK parameters: Cmax
Day 21
All parts: Assessment of PK parameters: Tmax
All parts:Assessment of PK parameters: AUC0-T
Day 21
Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs)
Year 2
Part 2A: Progression Free Survival (PFS)
Year 2
Part 2A: Objective Response Rate (ORR)
Day 30
All parts: Concentrations of cytokines
All parts: Incidence of anti-drug antibodies (ADAs) to SAR444200
Day 30
Part 2A: Number of participants with Adverse Events (AEs)
Day 30
Part 1A and 1B: Number of participants with Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Cancer

Trial Design

3 Treatment Groups

SAR444200 - Dose Escalation Phase (Part 1A)
1 of 3
SAR444200 - Dose Expansion Phase (Part 2A)
1 of 3
SAR444200 and Cemiplimab combination therapy - Dose Escalation Phase (Part 1B)
1 of 3
Experimental Treatment

106 Total Participants · 3 Treatment Groups

Primary Treatment: Cemiplimab · No Placebo Group · Phase 1 & 2

SAR444200 - Dose Escalation Phase (Part 1A)
Biological
Experimental Group · 1 Intervention: SAR444200 · Intervention Types: Biological
SAR444200 - Dose Expansion Phase (Part 2A)
Biological
Experimental Group · 1 Intervention: SAR444200 · Intervention Types: Biological
SAR444200 and Cemiplimab combination therapy - Dose Escalation Phase (Part 1B)Experimental Group · 2 Interventions: SAR444200, Cemiplimab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 1
~400

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of study (up to 2 years)
Closest Location: Investigational Site Number :1240001 · Quebec, Canada
2021First Recorded Clinical Trial
0 TrialsResearching Cancer
5 CompletedClinical Trials

Who is running the clinical trial?

SanofiLead Sponsor
2,021 Previous Clinical Trials
1,807,973 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
779 Previous Clinical Trials
568,137 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
At least 1 measurable lesion per RECIST 1.1 criteria.
You have metastatic non-small cell lung cancer (NSCLC) that is not amenable to standard of care.
GPC3 expression is positive in tumor tissue as determined locally or centrally.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.