SAR445877 Escalation Phase (Part 1) for Solid Tumors

Phase-Based Progress Estimates

1

Effectiveness

1

Safety

University of Texas MD Anderson Cancer Center-Site Number:8400005, Houston, TXSolid TumorsSAR445877 - Drug

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial will study a new drug to see if it is safe & effective to treat advanced cancers. Up to 240 people will take part.

Eligible Conditions

Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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a PD-1 inhibitor

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Study Objectives

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

Day 14

Dose escalation & expansion Assessment of SAR445877 AUC0-T

Dose escalation & expansion Assessment of SAR445877 Cmax

Day 14

Dose escalation: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2

Year 2

Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1

Disease

Time to response is defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed PR or CR determined by Investigator per RECIST 1.1

Year 2

Dose escalation Objective response rate (ORR)

Year 2

Dose expansion: Objective response rate (ORR)

Year 2

Dose escalation & expansion Duration of response (DoR)

Day 30

Dose escalation & expansion Incidence of anti-drug antibodies (ADAs) to SAR445877

Day 30

Therapeutic procedure

Day 30

Number of participants with Adverse events (AE)

Trial Safety

Safety Progress

1 of 3

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a PD-1 inhibitor

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Trial Design

5 Treatment Groups

SAR445877 Escalation Phase (Part 1)

1 of 5

SAR445877 Expansion Phase: Cohort A (Part 2)

1 of 5

SAR445877 Expansion Phase: Cohort B (Part 2)

1 of 5

SAR445877 Expansion Phase: Cohort C (Part 2)

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SAR445877 Expansion Phase: Cohort D (Part 2)

1 of 5

Experimental Treatment

240 Total Participants · 5 Treatment Groups

Primary Treatment: SAR445877 Escalation Phase (Part 1) · No Placebo Group · Phase 1 & 2

SAR445877 Escalation Phase (Part 1)

Drug

Experimental Group · 1 Intervention: SAR445877 · Intervention Types: Drug

SAR445877 Expansion Phase: Cohort A (Part 2)

Drug

Experimental Group · 1 Intervention: SAR445877 · Intervention Types: Drug

SAR445877 Expansion Phase: Cohort B (Part 2)

Drug

Experimental Group · 1 Intervention: SAR445877 · Intervention Types: Drug

SAR445877 Expansion Phase: Cohort C (Part 2)

Drug

Experimental Group · 1 Intervention: SAR445877 · Intervention Types: Drug

SAR445877 Expansion Phase: Cohort D (Part 2)

Drug

Experimental Group · 1 Intervention: SAR445877 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: from baseline to the end of study (up to 2 years)

Who is running the clinical trial?

Sanofi

SanofiLead Sponsor

2,051 Previous Clinical Trials

2,960,378 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

808 Previous Clinical Trials

1,627,216 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

This is a part of the study where they will be testing the safety of increasing the dosage of the study drug.

You have been diagnosed with advanced non-small cell lung cancer that has spread to other parts of your body.

You have been diagnosed with advanced stomach cancer that cannot be removed by surgery or has spread to other parts of the body, or a specific type of cancer where the esophagus meets the stomach.

For participants in Cohort C: You have a specific type of cancer called MSI or MMR, which will be determined by your local lab. You must have non-MSI-H or proficient MMR (pMMR) disease to participate.

If you are part of Cohort C, you need to know if you have HER2/neu positive or negative tumors. If you have HER2/neu negative tumors, you are eligible. If you have HER2/neu positive tumors, you must have tried an approved HER2 targeted therapy and have evidence of disease progression to be eligible.

You have advanced cancer that cannot be removed by surgery or has spread to other parts of your body. There are no other standard treatments available that would be better for you according to the doctor.

You have been diagnosed with advanced liver cancer that cannot be removed by surgery, or you meet the criteria for liver cancer set by the American Association for the Study of Liver Diseases if you have cirrhosis. If you don't have cirrhosis, your diagnosis must be confirmed through a biopsy.

For participants in Cohort C: Your tumor has a CPS score of less than 1 as determined by a local lab with an approved test. For other cohorts: Your tumor can have any CPS score and there is no need for CPS determination at a local lab.

You have a visible and measurable tumor as per the RECIST 1.1 criteria, and you understand and agree to participate in the study by signing the consent form.

References

2022. "A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05584670.

Frequently Asked Questions

Might an individual be able to participate in this clinical research endeavor?

"The trial is presently enrolling patients, according to clinicaltrials.gov reports. It was initially launched on the 29th of November 2022 and updated most recently on December 8th 2022." - Anonymous Online Contributor

Unverified Answer

What is the aggregate number of participants enrolled in this experiment?

"Confirmed. According to clinicaltrials.gov, this medical trial that first appeared on November 29th 2022 is presently recruiting participants. 240 candidates will be accepted from a single location for this investigation." - Anonymous Online Contributor

Unverified Answer

What objectives are researchers hoping to accomplish with this research initiative?

"The primary outcome of this investigation, which will be surveyed from the start to two years after dose expansion, is to assess any presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2. Secondary metrics that shall be assessed include incidences of anti-drug antibodies (ADAs), SAR445877 area under the concentration versus time curve calculated during a dosing interval (T), as well as adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 or American Society for Transplantation and Cellular Therapy consensus grading." - Anonymous Online Contributor

Unverified Answer

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

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