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.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
