A Phase I/Ib 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.

Study Identifier:
TED16925
CT.gov Identifier:
NCT05013554
EudraCT Identifier:
2021-000086-32
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

Considering participating in a START clinical trial?

Get Started

Study Summary

To determine the safety, effciacy and pharmacokinetics of SAR443216 in patients with relapsed/refractory HER2 expressing solid tumors.

To study the efficacy of SAR443216 administered intravenously (IV) or subcutaneously (SC) as a single agent in patients with HER2-expressing solid tumors

The study is conducted in 2 parts: The dose escalation part (n=∼70 dose limiting toxicity [DLT] evaluable patients) will assess safety and dose findings of SAR443216 using Bayesian-CRM model, in patients with HER2-expressing solid tumors who have exhausted all standard of care therapies. Dose expansion part (n=∼130 in 4 cohorts) will assess the safety and efficacy of SAR443216 at the recommended dose for expansion in cohorts defined by HER2-expression (1+, 2+ or 3+ by IHC) and/or HER2-activating mutations. Adverse events (AEs) are assessed per NCI CTCAE v5 and tumor response as per RECIST 1.1

To present safety, pharmacokinetics (PK), and biomarker data for 9 dose levels (DLs) of SAR443216 investigated in pts with advanced solid tumors in the IV dose-escalation cohort of a first-in-human open-label Phase 1/1b trial

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unspecified Cancer
Breast Cancers
Unmapped
Gastric
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: SAR443216-Dose Escalation
Read More
Drug: Experimental: SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A
Drug: Experimental: SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B
Drug: Experimental: SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C
Drug: Experimental: SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D
Drug: Experimental drug
Drug: ESMO 2024:
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
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.

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

View Study Information

Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Unspecified Cancer
Breast Cancers
Unmapped
Gastric