NCT05013554

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

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.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. * 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.

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.

Conditions

• Neoplasm Malignant
• Breast Cancer
• Lung Neoplasm Malignant
• Gastric Cancer
• Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-16
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2021-08-19
• Last updated: 2025-09-15

Locations

11 sites across 6 countries: United States, Belgium, France, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study