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

NCT05013554 | Terminated Phase 1 FDA Drug

• 4 other identifiers: TED16925U1111-1253-22332023-506852-26-002021-000086-32
• Study Type: interventional
• Target: 44
• Locations: 6 countries
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• Part 1: Objective response rate (ORR) of SAR443216 in all participants

  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

  From date of enrollment until the end of treatment, up to approximately 3.5 months

• Part 1 and Part 2: Progression Free Survival (PFS)

  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

  Baseline until the end of the study, up to approximately 9.5 months

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

  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

Study Arms (5)

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.

Drug: SAR443216 IV; Drug: SAR443216 SC

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.

Drug: SAR443216 IV

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.

Drug: SAR443216 IV

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.

Drug: SAR443216 IV

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

EXPERIMENTAL

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

Drug: SAR443216 IV

Interventions

SAR443216 IV DRUG

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

SAR443216-Dose Escalation; SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D; SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A; SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B; SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C

SAR443216 SC DRUG

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

SAR443216-Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

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

Houston, Texas, 77030, United States

Location

Investigational Site Number : 0560002

Ghent, 9000, Belgium

Location

Investigational Site Number : 2500001

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2500002

Villejuif, 94800, France

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240001

Madrid, Madrid, Comunidad de, 28040, Spain

Location

Investigational Site Number : 7240002

Madrid / Madrid, Madrid, Comunidad de, 28050, Spain

Location

Investigational Site Number : 1580001

Taichung, 404, Taiwan

Location

Investigational Site Number : 1580002

Tainan, 704, Taiwan

Location

Related Links

• TED16925 Plain Language Results Summary

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Lung Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: August 16, 2021
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (2); ES (3); US (1); TW (2); BE (1); KR (2)