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Anti-TGF-beta Monoclonal Antibody SAR-439459 for Cancer

Phase 1
Waitlist Available
Led By Timothy A Yap
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after completion of study treatment
Awards & highlights

Study Summary

This trial is testing a new drug combination to see if it is effective in shrinking advanced solid tumors or ones that cannot be removed by surgery.

Eligible Conditions
  • Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate (CBR)
Secondary outcome measures
Circulating-free deoxynucleic acid as a biomarker of response and resistance
Clinical benefit rate
Correlation of change in protein expression
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SAR439459, cemiplimab)Experimental Treatment2 Interventions
Patients receive SAR439459 IV over 30 minutes on day 1 and cemiplimab IV over 30 minutes on day 1 starting cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,011 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
533 Total Patients Enrolled
~1 spots leftby Jun 2025
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