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Monoclonal Antibodies

SAR408701 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For participants to the Expansion Phase cohorts: patients with CRC or with CEACAM5 positive non-squamous NSCLC, small cell lung cancer (SCLC) or gastric carcinoma (including esophago-gastric junction adenocarcinoma of the Siewert types II and III)

Locally advanced or metastatic solid malignant tumor disease for which no standard alternative therapy is available

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, SAR408701, to see if it is safe and effective. The primary objectives are to determine the maximum tolerated dose of the drug when given in different ways to patients with advanced solid tumors. Secondary objectives are to assess the drug's side effects, how it works in the body, and its potential to cause an immune reaction.

Who is the study for?

This trial is for adults with advanced solid tumors lacking standard treatment options. Ideal candidates have tumors likely expressing CEACAM5, including various cancers like colorectal and non-squamous lung cancer. They must have a measurable lesion or one suitable for biopsy and agree to contraception use if of reproductive potential.Check my eligibility

What is being tested?

SAR408701 is being tested in patients with advanced solid tumors to find the highest dose they can tolerate without severe side effects, given every two or three weeks. The study also aims to evaluate its effectiveness and safety profile.See study design

What are the potential side effects?

While specific side effects are not listed, common ones may include reactions at the infusion site, fatigue, nausea, changes in blood counts affecting immunity and clotting, liver or kidney function issues, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have CRC, CEACAM5 positive NSCLC, SCLC, or gastric cancer including certain types of esophago-gastric junction cancer.

Select...

My cancer is advanced or has spread, and there are no standard treatments left for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of overall response rate using standard imaging and RECIST 1.1 criteria

Number of dose limiting adverse events (every 2 week cycle)

Number of dose limiting adverse events (every 3 week cycle)

Secondary outcome measures

Accumulation ratio (Rac) on AUC0-14day and Cmax

Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W

Clearance at steady state (CLss)

+8 more

Trial Design

9Treatment groups

Experimental Treatment

Group I: SAR408701 Main Dose Escalation CohortExperimental Treatment1 Intervention

Dose escalation administered intravenously, once every two weeks

Group II: SAR408701 Loading Dose Escalation cohorts (Escalation bis)Experimental Treatment1 Intervention

Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks

Group III: SAR408701 Expansion Cohort small cell lung cancer (SCLC)Experimental Treatment1 Intervention

Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC

Group IV: SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)Experimental Treatment1 Intervention

Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity

Group V: SAR408701 Expansion Cohort non-squamous NSCLCExperimental Treatment1 Intervention

Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity

Group VI: SAR408701 Expansion Cohort gastric adenocarcinomaExperimental Treatment1 Intervention

Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma

Group VII: SAR408701 Expansion Cohort colorectal cancer (CRC-L)Experimental Treatment1 Intervention

Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks

Group VIII: SAR408701 Expansion Cohort colorectal cancer (CRC)Experimental Treatment1 Intervention

Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer

Group IX: SAR408701 Dose Escalation every 3 weeks cohortExperimental Treatment1 Intervention

Dose escalation administered intravenously, once every three weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR408701

2017

Completed Phase 1

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,165 Previous Clinical Trials

3,515,048 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

863 Previous Clinical Trials

2,019,914 Total Patients Enrolled

Frequently Asked Questions

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

How many research facilities are a part of this investigation?

"If you are interested in enrolling in this trial, know that there are 7 sites currently recruiting patients. These locations include Toronto, Boston and New Haven among others. To lessen the burden of travel, select the location nearest to you."

Answered by AI

Are patients currently being recruited for this clinical trial?

"While no longer recruiting patients, this study's posting on clinicaltrials.gov reports that it was last updated on 7/13/2022. This particular trial is not accepting candidates, however there are 2462 other studies that are still looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of SAR408701 in Patients With Advanced Solid Tumors

2014. "Evaluation of SAR408701 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02187848.