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NeoplasmPhase 1/2NCT05450562

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

A Phase 1/2 study testing SAR444200 and Atezolizumab in people with Neoplasm, run by Sanofi at 13 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm
What is being tested?
SAR444200 and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
13 sitesin 5 countries
Study dates
20 Sep 2022to 22 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.
  • NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

United States4 sites

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

    Houston, Texas, 77030

  • USC Norris Comprehensive Cancer Center- Site Number : 8400004

    Los Angeles, California, 90033

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

    New York, New York, 10029

  • Lifespan Corporation- Site Number : 8400002

    Providence, Rhode Island, 02903

Other trials in United States

Singapore3 sites

  • Investigational Site Number : 7020002

    Singapore, 119074

  • Investigational Site Number : 7020003

    Singapore, 169610

  • Investigational Site Number : 7020001

    Singapore, 308433

Other trials in Singapore

Canada2 sites

  • Investigational Site Number : 1240001

    Québec, Quebec, G1R 2J6

  • Investigational Site Number : 1240002

    Toronto, Ontario, M5G 2M9

Other trials in Canada

China2 sites

  • Investigational Site Number : 1560001

    Shanghai, 200120

  • Investigational Site Number : 1560002

    Wuhan, 430022

Other trials in China

South Korea2 sites

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06351

Other trials in South Korea

About this study

Official title: A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors.

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.

Read the 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
Being tested
SAR444200, Atezolizumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR444200Biological

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

  • AtezolizumabBiological

    Also called Tecentriq®

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

Study groups in NCT05450562
Study groupRoleWhat they receive
SAR444200 - Dose Escalation Phase (Part 1A)ExperimentalSAR444200 will be administered as intravenous injection as monotherapy in participants with GPC3+ solid tumors over a 21-day cycle
Receives: Biological: SAR444200
SAR444200 - Dose Expansion Phase (Part 2A)ExperimentalSAR444200 will be administered as intravenous injection in participants with GPC3+ NSCLC over a 21-day cycle
Receives: Biological: SAR444200
SAR444200 and Atezolizumab combination therapy - Dose Escalation Phase (Part 1B)ExperimentalSAR444200 in combination with atezolizumab will be administered as intravenous injection in participants with GPC3+ solid tumors over a 21-day cycle
Receives: Biological: SAR444200; Biological: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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

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

  3. 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)

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

Secondary outcomes (9)

  1. Part 1A and 1B: 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)

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

  2. All parts: Duration of response (DoR)

    DoR defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) or death from any cause, whichever occurs first determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: Baseline to end of study (up to 2 years)

  3. All parts: Assessment of PK parameters: Cmax

    Maximum plasma concentration observed

    Measured: Cycle 1 Day 1 to Day 21

  4. All parts:Assessment of PK parameters: AUC0-T

    Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (T)

    Measured: Cycle 1 Day 1to Day 21

  5. All parts: Assessment of PK parameters: Tmax

    Time to reach Cmax

    Measured: Cycle 1 Day 1to Day 21

  6. All parts: Incidence of anti-drug antibodies (ADAs) to SAR444200

    Incidence of participants with anti-drug antibodies to SAR444200

    Measured: From the first dose of Cycle to 30 days after last dose of study interventions. Cycle duration is 21 days

  7. All parts: Incidence of anti-drug antibodies (ADAs) to atezolizumab

    Measured: From the first dose of Cycle to 30 days after last dose of study interventions. Cycle duration is 21 days

  8. Part 2A: Progression Free Survival (PFS)

    PFS, defined as the time from the date of first IMP administration to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 (or death due to any cause, whichever occurs first)

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

  9. Part 2A: 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

    Measured: The time from the first dose of study interventions up to 30 days after last dose of study interventions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start20 Sep 2022
  3. Primary completion22 Dec 2025
  4. Study completion22 Dec 2025

Why it stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05450562
Sponsor's protocol ID
TCD17240
Other IDs
U1111-1264-3207, 2021-006623-17
Status last verified
Jan 2026
First submitted
5 Jul 2022
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SAR444200 and Atezolizumab in people with Neoplasm, run by Sanofi at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Singapore, Canada, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Early discontinuation based on strategic sponsor decision not driven by any safety concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs) (time frame: For Part 1A: from the Cycle 1, Day 1 up to Day 21For Part 1B: from Cycle 2 Day 1 up to Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05450562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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