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

• Status: Recruiting
• Trial end date: 2025-06-16
• Target enrollment: 0
• Participant gender: All

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 RP2D in the dose escalation part.

• To determine the maximum lead-in dose and the recommended target dose for phase 2.

• To determine the safety of SAR443216

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 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

• To evaluate the immunogenicity of SAR443216

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion Criteria:

• Participants must be ≥ 18 years of age

• Histologically proven diagnosis of advanced 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 a patient's potential participation in a clinical trial.