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

NCT05450562 | Terminated Phase 1 FDA Drug

• 3 other identifiers: TCD17240U1111-1264-32072021-006623-17
• Study Type: interventional
• Target: 33
• Locations: 5 countries
• Sites: 13

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.

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (3)

• Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs)

  Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  For Part 1A: from the Cycle 1, Day 1 up to Day 21For Part 1B: from Cycle 2 Day 1 up to Day 21

• Part 1A and 1B: Number of participants with Adverse Events (AEs)

  Incidence of treatment emergent AEs and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  the time from the first dose of study interventions up to 30 days after last dose of study interventions

• Part 2A: Objective Response Rate (ORR)

  ORR defined as the proportion of participants who have a complete response (CR) or partial response (PR) determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  From baseline to the end of expansion study (up to 2 years)

Secondary Outcomes (9)

• Part 1A and 1B: Objective Response Rate (ORR)

  Baseline to end of dose escalation study (up to 2 years)

• All parts: Duration of response (DoR)

  Baseline to end of study (up to 2 years)

• All parts: Assessment of PK parameters: Cmax

  Cycle 1 Day 1 to Day 21

• All parts:Assessment of PK parameters: AUC0-T

  Cycle 1 Day 1to Day 21

• All parts: Assessment of PK parameters: Tmax

  Cycle 1 Day 1to Day 21

Study Arms (3)

SAR444200 - Dose Escalation Phase (Part 1A)

EXPERIMENTAL

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

Biological: SAR444200

SAR444200 - Dose Expansion Phase (Part 2A)

EXPERIMENTAL

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

Biological: SAR444200

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

EXPERIMENTAL

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

Biological: SAR444200; Biological: Atezolizumab

Interventions

SAR444200 BIOLOGICAL

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

SAR444200 - Dose Escalation Phase (Part 1A); SAR444200 - Dose Expansion Phase (Part 2A); SAR444200 and Atezolizumab combination therapy - Dose Escalation Phase (Part 1B)

Atezolizumab BIOLOGICAL

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

Also known as: Tecentriq®

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer diagnosis for participants for Part 1A and Part 1B:
• 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
• 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:
• 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.
• 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:
• Positive GPC3 expression on tumor tissue as determined locally or centrally
• Capable of giving signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (13)

USC Norris Comprehensive Cancer Center- Site Number : 8400004

Los Angeles, California, 90033, United States

Location

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

New York, New York, 10029, United States

Location

Lifespan Corporation- Site Number : 8400002

Providence, Rhode Island, 02903, United States

Location

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

Houston, Texas, 77030, United States

Location

Investigational Site Number : 1240002

Toronto, Ontario, M5G 2M9, Canada

Location

Investigational Site Number : 1240001

Québec, Quebec, G1R 2J6, Canada

Location

Investigational Site Number : 1560001

Shanghai, 200120, China

Location

Investigational Site Number : 1560002

Wuhan, 430022, China

Location

Investigational Site Number : 7020002

Singapore, 119074, Singapore

Location

Investigational Site Number : 7020003

Singapore, 169610, Singapore

Location

Investigational Site Number : 7020001

Singapore, 308433, Singapore

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 06351, South Korea

Location

Related Links

• TCD17240 Plain Language Results Summary

MeSH Terms

Conditions

Neoplasms

Interventions

atezolizumab

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: September 20, 2022
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); CA (2); SG (3); US (4); CN (2)