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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
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
Study Summary
This trial is testing a new drug, SAR4443216, on people with solid tumors that express HER2. The first part of the trial is to determine the maximum tolerated dose (MTD) of the drug, the second part is to expand the dose to a larger group of people to assess preliminary clinical activity.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,436 Total Patients Enrolled
51 Trials studying Breast Cancer
24,185 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have or had lung inflammation or scarring.I have ongoing kidney problems that are not under control.I have at least one tumor that can be measured by medical imaging.I have had a transplant of an organ or bone marrow.I am fully active or can carry out light work.I am 18 years old or older.My cancer has spread and was confirmed by a lab test.My blood, liver, and kidney functions are not normal.My weight is between 45 and 150 kg.I am able to understand and sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C
- Group 2: SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B
- Group 3: SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D
- Group 4: SAR443216-Dose Escalation
- Group 5: SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What results is this clinical experiment intending to demonstrate?
"As the primary goal of this research, investigators will measure the maximum tolerated dose and recommended phase 2 dose for SAR443216 over a period up to 7.5 months from baseline. Other objectives include assessing duration of response, safety profiles evaluated through adverse events, serious adverse events and lab abnormalities in participants as well as objective response rate based on RECIST v1.1 criteria."
Answered by AI
How many patients have been accepted to participate in this medical trial?
"Affirmative, the clinicaltrials.gov platform confirms that this trial is presently recruiting applicants. The project was initially posted on August 16th 2021 and recently updated on October 31st 2022. This experiment requires 200 test subjects from 3 distinct sites to be enrolled."
Answered by AI
Are there still opportunities to become involved in this clinical trial?
"Patient recruitment for this clinical trial is currently underway. The information posted to clinicaltrials.gov shows that the study was first published on August 16th 2021 and has recently been updated as of October 31st 2022."
Answered by AI
Has SAR443216 gone through the processes necessary to gain FDA authorization?
"As this is the first trial of SAR443216, our team at Power surmised that its safety was best evaluated with a score of 1. This reflects the limited available data on efficacy and security associated with it."
Answered by AI
Who else is applying?
What site did they apply to?
~University of Texas - MD Anderson Cancer Center-Site Number:8400002
What portion of applicants met pre-screening criteria?
Did not meet criteria
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