Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 15, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Sanofi
- Interventions being studied
- Drug: SAR443216 IV; Drug: SAR443216 SC
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- ~University of Texas - MD Anderson Cancer Center Site Number : 8400002Houston, Texas
- Investigational Site Number : 0560002Ghent
- Investigational Site Number : 2500001Pierre-Bénite
- Investigational Site Number : 2500002Villejuif
- Investigational Site Number : 4100001Seoul, Seoul-teukbyeolsi
- Investigational Site Number : 4100002Seoul, Seoul-teukbyeolsi
- Investigational Site Number : 7240003Barcelona, Barcelona [Barcelona]
- Investigational Site Number : 7240001Madrid, Madrid, Comunidad de
- Investigational Site Number : 7240002Madrid / Madrid, Madrid, Comunidad de
- Investigational Site Number : 1580001Taichung
- Investigational Site Number : 1580002Tainan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 15, 2025. Always confirm current availability with the study team.