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

Phase 1 Study of an Investigational Medication for HER2 Expressing Solid Tumors

Not Recruiting
18 years or above
All
Phase 1
44 participants needed

Study Overview

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.

Study Details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neoplasm Malignant, Breast Cancer, Lung Neoplasm Malignant, Gastric Cancer, Neoplasm
  • Age: 18 years or above
  • Gender: All

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
  • 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

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.

Updated on 09 Feb 2024. Study ID: NCT05013554

This study investigates an investigational medication for people with HER2 expressing solid tumors. HER2 is a protein that can affect the growth of some cancer cells. The study aims to find the best dose of the investigational medication when given by injection under the skin or directly into a vein. It will also look at how safe the medication is for participants with different levels of HER2 expression in their tumors.

Participants in the study will receive the investigational medication either as an injection under the skin or directly into a vein. The study will monitor the effects of the medication on the body, including how it moves through the body and the body's immune response to it. Participants will have regular check-ups to see how their bodies are reacting to the treatment.

  • Who can participate: Adults aged 18 and older with metastatic solid tumors that express HER2 can participate. They must have a good performance status and at least one measurable disease. Participants should also have a body weight between 45 and 150 kg.
  • Study details: Participants will have regular check-ups to monitor the effects of the investigational medication, including its safety and the body's response.
  • Study Timelines: The study will last 7.5 months for the dose escalation part and 9.5 months for the dose expansion part.