Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

NCT ID: NCT05013554

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-01-15

Brief Summary

Primary Objectives:

Part 1 (Dose Escalation)

• To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part.
• To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration.

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

• To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration.
• To evaluate the immunogenicity of SAR443216 after IV and SC administration.
• 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.

Detailed Description

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:

• 7.5 months (up to 1 month for screening, a median of 3.5 months for treatment, and a median of 3 months for long term follow-up) in escalation.
• 9.5 months (up to 1 month for screening, a median of 5.5 months for treatment, and a median of 3 months for long term follow-up) in expansion.

Conditions

Neoplasm Malignant; Breast Cancer; Lung Neoplasm Malignant; Gastric Cancer; Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR443216-Dose Escalation

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.

Group Type: EXPERIMENTAL

SAR443216 IV

Intervention Type: DRUG

Pharmaceutical form: Powder for solution; Route of administration: IV infusion

SAR443216 SC

Intervention Type: DRUG

Pharmaceutical form: Powder for solution; Route of administration: SC injection

SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A

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

Group Type: EXPERIMENTAL

SAR443216 IV

Intervention Type: DRUG

Pharmaceutical form: Powder for solution; Route of administration: IV infusion

SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B

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

Group Type: EXPERIMENTAL

SAR443216 IV

Intervention Type: DRUG

Pharmaceutical form: Powder for solution; Route of administration: IV infusion

SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C

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

Group Type: EXPERIMENTAL

SAR443216 IV

Intervention Type: DRUG

Pharmaceutical form: Powder for solution; Route of administration: IV infusion

SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D

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

Group Type: EXPERIMENTAL

SAR443216 IV

Intervention Type: DRUG

Pharmaceutical form: Powder for solution; Route of administration: IV infusion

Interventions

SAR443216 IV

Pharmaceutical form: Powder for solution; Route of administration: IV infusion

Intervention Type: DRUG

SAR443216 SC

Pharmaceutical form: Powder for solution; Route of administration: SC injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must be ≥ 18 years of age
• Histologically or cytologically confirmed diagnosis of metastatic solid tumors
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• All participants should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
• Body weight within [45 - 150 kg] (inclusive)
• All Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent

Exclusion Criteria

• Any clinically significant cardiac disease
• History of or current interstitial lung disease or pneumonitis
• Uncontrolled or unresolved acute renal failure
• Prior solid organ or hematologic transplant.
• Known positivity with human immunodeficiency virus (HIV), known active hepatitis A, B, and C, or uncontrolled chronic or ongoing infectious requiring parenteral treatment.
• Receipt of a live-virus vaccination within 28 days of planned treatment start
• Participation in a concurrent clinical study in the treatment period.
• Inadequate hematologic, hepatic and renal function
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

~University of Texas - MD Anderson Cancer Center Site Number : 8400002

Houston, Texas, United States

Investigational Site Number : 0560002

Ghent, , Belgium

Investigational Site Number : 2500001

Pierre-Bénite, , France

Investigational Site Number : 2500002

Villejuif, , France

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240001

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240002

Madrid / Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 1580001

Taichung, , Taiwan

Investigational Site Number : 1580002

Tainan City, , Taiwan

Countries

United States; Belgium; France; South Korea; Spain; Taiwan

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25361&tenant=MT_SNY_9011

TED16925 Plain Language Results Summary

Other Identifiers

U1111-1253-2233

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506852-26-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-000086-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TED16925

Identifier Type: -

Identifier Source: org_study_id