SAR443216 for Cancer

No longer recruiting at 43 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sanofi

Disqualifiers: Cardiac disease, Lung disease, Renal failure, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR443216 for people with certain types of cancer that have spread (metastasized). It focuses on tumors that show a protein called HER2, which can influence cancer growth. The trial will assess the safety of this treatment and its effects on cancer. People diagnosed with metastatic breast, gastric, or lung cancer with HER2 expression might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that SAR443216 is likely to be safe for humans?

Research has shown that SAR443216 is generally well-tolerated by people with HER2-positive solid tumors. Studies have found that most patients experience mild and manageable side effects. Importantly, no reports of severe or life-threatening side effects have been linked to the treatment. This suggests the treatment is safe enough for further testing, although some side effects may still occur. Overall, current evidence supports the continued study of SAR443216 in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about SAR443216 because it targets HER2 expressions and mutations in various cancers, which is a different approach compared to traditional HER2-targeted therapies like trastuzumab or pertuzumab. SAR443216 is designed to be versatile, addressing both low and high HER2 expression and mutations without amplification, providing options for patients who might not respond to existing treatments. This treatment is also notable for its administration flexibility, as it can be delivered either intravenously or subcutaneously, potentially offering more convenience and better patient compliance.

What evidence suggests that SAR443216 might be an effective treatment for HER2 expressing solid tumors?

Studies have shown that SAR443216 targets HER2, a protein often found in high amounts in some cancers, and has manageable side effects. This treatment helps the immune system identify and attack cancer cells by focusing on tumors with high HER2 levels. In earlier studies, SAR443216 showed promise in patients with HER2-positive solid tumors, such as breast and stomach cancers, without any severe or life-threatening side effects reported. The ongoing trial includes various treatment arms to determine the best dose and further explore its potential in treating cancers with different HER2 expression levels, including metastatic breast cancers, gastric cancers, and non-small cell lung cancer (NSCLC). ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

My cancer has spread and was confirmed by a lab test.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. onclive.com onclive.com/view/sar443216-engages-her2-with-manageable-toxicity-in-advanced-her2-solid-tumors

SAR443216 Engages HER2 With Manageable Toxicity in ... SAR443216 showed manageable toxicity in HER2-positive solid tumors, with no severe or fatal treatment-related adverse events reported. The trial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05013554

NCT05013554 | Dose Escalation and Expansion Study of ... Participants with metastatic NSCLC with HER2 low or high expression and/or HER2 mutation will receive SAR443216 as intravenous (IV) infusion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10177527/

Preclinical and Basic Research Strategies for Overcoming ... Metastatic breast cancers with HER2 low expression, SAR443216, No results ... Notably, in HER2-positive BC cell lines, PHF8 expression was elevated after HER2 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9367369/

Targeted Approaches to HER2-Low Breast Cancer Unfortunately, the low HER2 expression failed to provide clinical prognosis benefits. The available HER2-targeted therapies are inefficient in ...

5. researchgate.net researchgate.net/publication/352918562_Abstract_1825_SAR443216_a_novel_trispecific_T_cell_engager_with_potent_T_cell-dependent_cytotoxicity_for_HER2-low_tumors

SAR443216, a novel trispecific T cell engager with potent T ... IHC confirmed persistent CEACAM6 expression in RD tumors post-NAC. Clinically, pCR patients had higher lymphocyte counts and more frequent N2–N3 nodal status.

6. esmoopen.com esmoopen.com/article/S2059-7029(25)00067-5/pdf

SAR443216 in patients (pts) with advanced so Here, we present safety, PK, and biomarker data for. 9 dose levels (DLs) of SAR443216 in pts with advanced solid tumors in the IV dose- escalation cohort of a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9640784/

Targeting HER2-positive breast cancer - PubMed Central HER2 expression is associated with poor prognosis, including early recurrence and metastatic disease in breast cancer3,260,261.