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Neoplasm MalignantPhase 1NCT05013554

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

A Phase 1 study testing SAR443216 IV and SAR443216 SC in people with Neoplasm Malignant and Breast Cancer, run by Sanofi at 11 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAR443216 IV and SAR443216 SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
11 sitesin 6 countries
Study dates
16 Aug 2021to 15 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

11 sites in 6 countries.

11 sites in 6 countries

Spain3 sites

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240001

    Madrid, Madrid, Comunidad de, 28040

  • Investigational Site Number : 7240002

    Madrid / Madrid, Madrid, Comunidad de, 28050

Other trials in Spain

France2 sites

  • Investigational Site Number : 2500001

    Pierre-Bénite, 69495

  • Investigational Site Number : 2500002

    Villejuif, 94800

Other trials in France

South Korea2 sites

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 05505

Other trials in South Korea

Taiwan2 sites

  • Investigational Site Number : 1580001

    Taichung, 404

  • Investigational Site Number : 1580002

    Tainan, 704

Other trials in Taiwan

United States1 site

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

    Houston, Texas, 77030

Other trials in United States

Belgium1 site

  • Investigational Site Number : 0560002

    Ghent, 9000

Other trials in Belgium

About this study

Official title: A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors.

Primary Objectives:

Part 1 (Dose Escalation)

Read more
  • 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.
Read the 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.
Being tested
SAR443216 IV, SAR443216 SC
Medical subject headings
Neoplasms, Breast Neoplasms, Lung Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR443216 IVDrug

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

  • SAR443216 SCDrug

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

Study groups in NCT05013554
Study groupRoleWhat they receive
SAR443216-Dose EscalationExperimentalParticipants 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.
Receives: Drug: SAR443216 IV; Drug: SAR443216 SC
SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort AExperimentalParticipants with metastatic breast cancers with HER2 high expression (with amplification) will receive SAR443216 as intravenous (IV) infusion.
Receives: Drug: SAR443216 IV
SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort BExperimentalParticipants with metastatic breast cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion.
Receives: Drug: SAR443216 IV
SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort CExperimentalParticipants with metastatic gastric cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion.
Receives: Drug: SAR443216 IV
SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort DExperimentalParticipants with metastatic NSCLC with HER2 low or high expression and/or HER2 mutation will receive SAR443216 as intravenous (IV) infusion.
Receives: Drug: SAR443216 IV

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence of study dose limiting toxicities (DLTs)

    Measured: Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule

  2. 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.

    Measured: Baseline until end of study, up to approximately 7.5 months

  3. 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.

    Measured: From date of enrollment until the end of treatment, up to approximately 5.5 months

  4. 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.

    Measured: From date of enrollment until the end of treatment, up to approximately 5.5 months

Secondary outcomes (9)

  1. 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.

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

  2. Part 1: 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

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

  3. 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

    Measured: From date of enrollment until the end of treatment, up to approximately 3.5 months for Part1 and 5.5 months for Part 2

  4. 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

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

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

    Maximum observed plasma concentration

    Measured: 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

  6. Part 1 and Part 2: Pharmacokinetic Parameter: Ctrough of SAR443216

    Plasma concentration observed just before treatment administration during repeated dosing

    Measured: 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

  7. Part 1 and Part 2: Pharmacokinetic Parameter: t 1/2 of SAR443216

    Terminal half-life associated with the terminal slope (λz)

    Measured: 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

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

    Area under the plasma concentration versus time curve

    Measured: 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

  9. Part 1 and Part 2: Evaluation of SAR443216 immunogenicity

    Incidence of ADA induction and ADA persistence

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start16 Aug 2021
  3. Primary completion15 Jan 2024
  4. Study completion15 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05013554
Sponsor's protocol ID
TED16925
Other IDs
U1111-1253-2233, 2023-506852-26-00, 2021-000086-32, 2023
Status last verified
Sep 2025
First submitted
12 Aug 2021
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Dumbrava EE, Oh DY, Ryu MH, Calvo E, Garralda E, Chung WP, Bai LY, Rojas K, Yildirim O, Masciari S, Mi G, Wang L, Rotolo F, Gailhac S, Attieh E, Kanlikilicer P, Buday B, Perez R, Rharbaoui F, Abbadessa G, Moreno V. Phase 1/1b open-label, first-in-human study of HER2xCD3xCD28 trispecific T-cell engager (SAR443216) in participants with R/R HER2-expressing solid tumors. J Immunother Cancer. 2026 Sep 7;14(9):e014309. doi: 10.1136/jitc-2025-014309.

    PubMed 42705861

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR443216 IV and SAR443216 SC in people with Neoplasm Malignant and Breast Cancer, run by Sanofi at 11 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain, France, South Korea, Taiwan, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216 (time frame: Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05013554, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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