SAR443216 for Cancer

Recruiting at 37 trial locations

Overseen By email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sanofi

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called SAR443216 to see if it is safe and effective for patients with certain types of cancer that have a protein called HER2. The drug works by targeting and attacking these cancer cells.

Eligibility Criteria

This trial is for adults over 18 with advanced solid tumors expressing HER2, who have measurable disease and are in good physical condition (ECOG 0-1). They must weigh between 45-150 kg and use approved contraception. Exclusions include significant heart disease, uncontrolled kidney failure, lung conditions like pneumonitis, transplants, HIV or active hepatitis infections, recent live vaccines, or other clinical study participation.

Inclusion Criteria

I have at least one tumor that can be measured by medical imaging.

I am fully active or can carry out light work.

I am 18 years old or older.

Exclusion Criteria

You have HIV, active hepatitis A, B, or C, or a serious, ongoing infection that needs injections for treatment.

I have not received a live-virus vaccine in the last 28 days.

I have a serious heart condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 1 month

Dose Escalation

Determine the maximum tolerated dose (MTD) and assess safety of SAR443216 in participants with HER2 expressing solid tumors

3.5 months

Multiple visits for dose administration and monitoring

Dose Expansion

Assess preliminary clinical activity and safety of SAR443216 at recommended doses in participants with HER2 expressing solid tumors

5.5 months

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• SAR443216

Trial Overview The trial tests SAR443216's maximum tolerable dose when given intravenously (IV) or subcutaneously (SC) to patients with HER2+ tumors. It aims to find the safest dose level and assess how well it works against different levels of HER2 expression in cancers such as breast and stomach cancer.

Participant Groups

Group I: SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C Experimental Treatment 1 Intervention

Participants with metastatic gastric cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion.

Group II: SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B Experimental Treatment 1 Intervention

Participants with metastatic breast cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion.

Group III: SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A Experimental Treatment 1 Intervention

Participants with metastatic breast cancers with HER2 high expression (with amplification) will receive SAR443216 as intravenous (IV) infusion.

Group IV: SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D Experimental Treatment 1 Intervention

Participants with metastatic NSCLC with HER2 low or high expression and/or HER2 mutation will receive SAR443216 as intravenous (IV) infusion.

Group V: SAR443216-Dose Escalation Experimental Treatment 2 Interventions

Participants with metastatic solid tumors that express HER2 in tumor tissue and/or with HER2 aberration will receive SAR443216 as intravenous (IV) infusion or subcutaneous (SC) injection.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University