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 RP2D 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 SAR4443216 at the RP2D 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 R2PD 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 R2PD in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
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.
Drug: SAR443216 IV
Pharmaceutical form: Powder for solution; Route of administration: IV infusion
Drug: SAR443216 SC
Pharmaceutical form: Powder for solution; Route of administration: SC injection
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
- Participants must have HER2 expression in tumor tissue and/or with HER2 aberration
detected in tumor or blood by means of validated assay(s)
- Body weight within [45 - 150 kg] (inclusive)
- Male and female participants including woman of childbearing potential must agree to
follow contraceptive guidance
- 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.
~University of Texas - MD Anderson Cancer Center-Site Number:8400002
Houston, Texas, United States
Investigational Site Number :4100001
Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100002
Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :7240003
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240002
Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number :7240001
Madrid, Madrid, Comunidad De, Spain
Investigational Site Number :1580001
Taichung City, Taiwan
Investigational Site Number :1580002
Tainan, Taiwan
email recommended (Toll free number for US & Canada)
800-633-1610 - Option 6
Contact-US@sanofi.com