What side effects are associated with this type of intervention?

Common treatments for HER2-positive breast cancer, such as trastuzumab and lapatinib, have specific side effects. Trastuzumab can cause chills, fever, nausea, vomiting, weakness, headache, and potentially serious cardiac dysfunction. Lapatinib, often used in combination with trastuzumab, may lead to diarrhea, rash, erythema, and hepatic adverse events. Patients should discuss these potential side effects with their healthcare providers to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several HER2-targeted therapies for breast cancer. Notable among these are trastuzumab (Herceptin), which was one of the first HER2-targeted therapies, and its conjugates like fam-trastuzumab deruxtecan (Enhertu) and ado-trastuzumab emtansine (Kadcyla). These drugs are used for patients with HER2-positive breast cancer, including those with metastatic disease. Fam-trastuzumab deruxtecan is approved for patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy. These therapies have shown significant efficacy in improving progression-free survival and overall response rates in clinical trials.

What other types of research exist?

Promising novel alternatives to SAR443216 for HER2-targeted therapy in breast cancer include: 1) Trastuzumab deruxtecan (an ADC showing efficacy in various trials), 2) Combinations of trastuzumab with pertuzumab and docetaxel, and 3) Emerging therapies from ongoing clinical trials focusing on innovative combinations and reduced toxicity.

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Monoclonal Antibodies

SAR443216 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

Participants must be ≥ 18 years of age

Histologically or cytologically confirmed diagnosis of metastatic solid tumors

Must not have

Any clinically significant cardiac disease

History of or current interstitial lung disease or pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment until the end of treatment, up to approximately 3.5 months for part1 and 5.5 months for part 2

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer treatments like SAR443216 may include reactions at the injection site for SC doses; infusion-related reactions for IV doses; fatigue; nausea; blood count changes affecting immunity; potential liver or kidney function alterations.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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

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I am fully active or can carry out light work.

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

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My weight is between 45 and 150 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have or had lung inflammation or scarring.

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I have ongoing kidney problems that are not under control.

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I have had a transplant of an organ or bone marrow.

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

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My blood, liver, and kidney functions are not normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until the end of treatment, up to approximately 3.5 months for part1 and 5.5 months for part 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment until the end of treatment, up to approximately 3.5 months for part1 and 5.5 months for part 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until the end of treatment, up to approximately 3.5 months for part1 and 5.5 months for part 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216

Part 1: Dose Escalation: Safety of SAR443216

Part 2: Dose Expansion Duration of response (DoR) of SAR443216 in all participants.

+1 more

Secondary study objectives

Part 1 and Part 2: Evaluation of SAR443216 immunogenicity

Part 1 and Part 2: Pharmacokinetic Parameter: AUC0-τ of SAR443216

Part 1 and Part 2: Pharmacokinetic Parameter: Cmax of SAR443216

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort CExperimental Treatment1 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 BExperimental Treatment1 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 AExperimental Treatment1 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 DExperimental Treatment1 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 EscalationExperimental Treatment2 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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

HER2-targeted therapies, such as trastuzumab and T-DM1, are common treatments for HER2-positive breast cancer. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor on cancer cells, inhibiting their growth and survival. T-DM1 combines trastuzumab with a cytotoxic agent, delivering targeted chemotherapy directly to HER2-positive cells. These treatments are crucial for breast cancer patients as they specifically target cancer cells with minimal impact on normal cells, improving progression-free and overall survival rates while reducing severe side effects compared to traditional chemotherapy.

Challenges in the diagnosis and management of cervical neuroendocrine carcinoma.Pharmacokinetic and pharmacodynamic evaluation of panitumumab in the treatment of colorectal cancer.Pharmacokinetics, clinical indications, and resistance mechanisms in molecular targeted therapies in cancer.