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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-2233 | Registry Identifier | ICTRP | |
| 2023-506852-26-00 | Registry Identifier | CTIS | |
| 2021-000086-32 | EudraCT Number |
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Primary Objectives:
Part 1 (Dose Escalation)
Part 2 (Dose expansion)
• To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Secondary Objectives:
Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Part 2
• To determine the safety of SAR443216.
Part 1 and 2
The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant is estimated to be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR443216-Dose Escalation | Experimental | 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. |
|
| SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A | Experimental | Participants with metastatic breast cancers with HER2 high expression (with amplification) will receive SAR443216 as intravenous (IV) infusion. |
|
| SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B | Experimental | Participants with metastatic breast cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion. |
|
| SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C | Experimental | Participants with metastatic gastric cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion. |
|
| SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR443216 IV | Drug | Pharmaceutical form: Powder for solution; Route of administration: IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216 | Incidence of study dose limiting toxicities (DLTs) | Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule |
| Part 1: Dose Escalation: Safety of SAR443216 | Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and lab abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Baseline until end of study, up to approximately 7.5 months |
| Part 2: Dose Expansion Objective response rate (ORR) of SAR443216 in all participants | Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) per RECIST v1.1. | From date of enrollment until the end of treatment, up to approximately 5.5 months |
| Part 2: Dose Expansion Duration of response (DoR) of SAR443216 in all participants. | Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first. | From date of enrollment until the end of treatment, up to approximately 5.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Objective response rate (ORR) of SAR443216 in all participants | Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) per RECIST v1.1. | From date of enrollment until the end of treatment, up to approximately 3.5 months |
| Part 1: Duration of response (DoR) of SAR443216 in all participants |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ~University of Texas - MD Anderson Cancer Center Site Number : 8400002 | Houston | Texas | 77030 | United States | ||
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| Label | URL |
|---|---|
| TED16925 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Participants with metastatic NSCLC with HER2 low or high expression and/or HER2 mutation will receive SAR443216 as intravenous (IV) infusion. |
|
| SAR443216 SC | Drug | Pharmaceutical form: Powder for solution; Route of administration: SC injection |
|
Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first |
| From date of enrollment until the end of treatment, up to approximately 3.5 months |
| Part 1 and Part 2: Progression Free Survival (PFS) | Progression free survival (PFS) will be assessed by the Investigator per RECIST v1.1 and will be summarized using the Kaplan-Meier method | From date of enrollment until the end of treatment, up to approximately 3.5 months for Part1 and 5.5 months for Part 2 |
| Part 2: Safety of SAR443216 | Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and lab abnormalities according to NCI CTCAE Version 5.0 | Baseline until the end of the study, up to approximately 9.5 months |
| Part 1 and Part 2: Pharmacokinetic Parameter: Cmax of SAR443216 | Maximum observed plasma concentration | From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2 |
| Part 1 and Part 2: Pharmacokinetic Parameter: Ctrough of SAR443216 | Plasma concentration observed just before treatment administration during repeated dosing | From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2 |
| Part 1 and Part 2: Pharmacokinetic Parameter: t 1/2 of SAR443216 | Terminal half-life associated with the terminal slope (λz) | From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2 |
| Part 1 and Part 2: Pharmacokinetic Parameter: AUC0-τ of SAR443216 | Area under the plasma concentration versus time curve | From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2 |
| Part 1 and Part 2: Evaluation of SAR443216 immunogenicity | Incidence of ADA induction and ADA persistence | From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2 |
| Investigational Site Number : 0560002 |
| Ghent |
| 9000 |
| Belgium |
| Investigational Site Number : 2500001 | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2500002 | Villejuif | 94800 | France |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number : 7240003 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number : 7240001 | Madrid | Madrid, Comunidad de | 28040 | Spain |
| Investigational Site Number : 7240002 | Madrid / Madrid | Madrid, Comunidad de | 28050 | Spain |
| Investigational Site Number : 1580001 | Taichung | 404 | Taiwan |
| Investigational Site Number : 1580002 | Tainan | 704 | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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