Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

NCT ID: NCT05450562

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2025-12-22

Brief Summary

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Detailed Description

Treatment Period: enrolled participants will receive continuous treatment until disease progression (PD), unacceptable adverse event (AE), or other permanent discontinuation criteria.

The End of Treatment visit will occur 30 days ±7 days from last IMP administration or prior to initiation of further therapy, whichever occurs first.

Conditions

Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR444200 - Dose Escalation Phase (Part 1A)

SAR444200 will be administered as intravenous injection as monotherapy in participants with GPC3+ solid tumors over a 21-day cycle

Group Type: EXPERIMENTAL

SAR444200

Intervention Type: BIOLOGICAL

Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

SAR444200 - Dose Expansion Phase (Part 2A)

SAR444200 will be administered as intravenous injection in participants with GPC3+ NSCLC over a 21-day cycle

Group Type: EXPERIMENTAL

SAR444200

Intervention Type: BIOLOGICAL

Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

SAR444200 and Atezolizumab combination therapy - Dose Escalation Phase (Part 1B)

SAR444200 in combination with atezolizumab will be administered as intravenous injection in participants with GPC3+ solid tumors over a 21-day cycle

Group Type: EXPERIMENTAL

SAR444200

Intervention Type: BIOLOGICAL

Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

Atezolizumab

Intervention Type: BIOLOGICAL

concentrate for solution for infusion Route of administration: intravenous (IV) infusion

Interventions

SAR444200

Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

Intervention Type: BIOLOGICAL

Atezolizumab

concentrate for solution for infusion Route of administration: intravenous (IV) infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

Tecentriq®

Eligibility Criteria

Inclusion Criteria

• Cancer diagnosis for participants for Part 1A and Part 1B:

1. Metastatic and/or unresectable HCC diagnosed by histology and/or cytology, or diagnosed clinically by the American Association for the Study of Liver Diseases (AASLD) criteria for participants with liver cirrhosis (participants without liver cirrhosis must be diagnosed histologically) OR Other histology/cytology proven advanced and/or metastatic non-HCC solid tumors

2. Not amenable to available standard of care: participants must have experienced disease progression on/after standard of care, or no acceptable standard curative or palliative treatments exist (or are no longer effective), according to Investigator judgement, or the participant declines standard of care therapy.

• Cancer diagnosis for participants for Part 2A:

1. Metastatic NSCLC with no actionable driver gene mutants (such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK)), diagnosed by histology and/or cytology not amenable to available standard of care and must have progressed on/after therapy that included an anti-PD(L)-1 agent with or without platinum-based chemotherapy.

2. Progressive disease should be observed during the course of anti-PD(L)-1 therapy or within 12 weeks from the last dose of anti-PD(L)-1 therapy

• Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria
• For all participants:

1. Positive GPC3 expression on tumor tissue as determined locally or centrally

2. Capable of giving signed informed consent

Exclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
• Predicted life expectancy ≤3 months.
• For participants with HCC: Child Pugh Class B or C liver score within 14 days of initiation of IMP. Participants with Child Pugh Class B-7 score are allowed for Part 1A.
• Known active brain metastases or leptomeningeal metastases.
• History of allogenic or solid organ transplant
• Treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity
• Significant cardiovascular disease within 3 months prior to initiation of IMP, uncontrolled arrhythmia requiring medication, or unstable angina.
• Ongoing AEs caused by any prior anti-cancer therapy >Grade 2
• Known uncontrolled human immunodeficiency virus (HIV), hepatitis B infection, or known untreated current hepatitis C infection
• Known second malignancy either progressing or requiring active treatment within the last year.
• For combination therapy: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
• Receipt of a live-virus vaccination within 28 days of planned treatment start.
• For Part 2A, has received prior GPC3 targeted anticancer treatment.
• Current pneumonitis or interstitial lung disease, or history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

USC Norris Comprehensive Cancer Center- Site Number : 8400004

Los Angeles, California, United States

Icahn School of Medicine at Mount Sinai- Site Number : 8400005

New York, New York, United States

Lifespan Corporation- Site Number : 8400002

Providence, Rhode Island, United States

The University of Texas MD Anderson Cancer Center- Site Number : 8400003

Houston, Texas, United States

Investigational Site Number : 1240002

Toronto, Ontario, Canada

Investigational Site Number : 1240001

Québec, Quebec, Canada

Investigational Site Number : 1560001

Shanghai, , China

Investigational Site Number : 1560002

Wuhan, , China

Investigational Site Number : 7020002

Singapore, , Singapore

Investigational Site Number : 7020003

Singapore, , Singapore

Investigational Site Number : 7020001

Singapore, , Singapore

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Countries

United States; Canada; China; Singapore; South Korea

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25349&tenant=MT_SNY_9011

TCD17240 Plain Language Results Summary

Other Identifiers

U1111-1264-3207

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-006623-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TCD17240

Identifier Type: -

Identifier Source: org_study_id