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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after completion of study treatment

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,516 Total Patients Enrolled

Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center

9 Previous Clinical Trials

533 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SAR-439459 Anti-TGF-beta Monoclonal Antibody been assessed in previous clinical research?

"Presently, 56 clinical trials looking into Anti-TGF-beta Monoclonal Antibody SAR-439459 are in progress with 4 of them being Phase 3. Barcelona and California host the largest number of studies however 1741 locations worldwide are running investigations concerning this antibody."

Answered by AI

How many participants are actively involved in this clinical trial?

"At this moment, no new patients are being admitted to the clinical trial. The study was uploaded on February 9th 2021 and its most recent update occured last year on February 9th 2022. If you seek other trials, 2396 cancer studies and 56 Anti-TGF-beta Monoclonal Antibody SAR-439459 trials remain open for enrollment."

Answered by AI

How have clinical studies evaluated the security of SAR-439459 Anti-TGF-beta Monoclonal Antibody?

"Data related to the safety and efficacy of Anti-TGF-beta Monoclonal Antibody SAR-439459 is limited, so it received a rating of 1."

Answered by AI

What conditions are typically alleviated by the application of Anti-TGF-beta Monoclonal Antibody SAR-439459?

"SAR-439459, an anti-TGF-beta monoclonal antibody, is typically employed to treat alk gene mutations. It can also be useful for a range of other medical problems such as drafting advance directives and managing malignant neoplasms or metastatic cutaneous squamous cell carcinoma."

Answered by AI

Are individuals still able to enrol in this research study?

"Unfortunately, this trial has stopped recruiting patients. It was first posted on 2nd of September 2021 and then edited 12 months later with no further modifications. For those seeking alternate clinical trials, there are 2396 cancer-related studies that are still accepting enrolment as well as 56 recruitment slots open to receive Anti-TGF-beta Monoclonal Antibody SAR-439459 applicants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL

2021. "SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729725.