Experimental cancer drug trial halted early
NCT ID NCT05450562
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called SAR444200, alone or with other cancer treatments, in 33 adults with advanced solid tumors that had spread and were not responding to standard therapy. The main goals were to check safety and find the right dose. The trial was terminated early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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33 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai- Site Number : 8400005
New York, New York, 10029, United States
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Investigational Site Number : 1240001
Québec, Quebec, G1R 2J6, Canada
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Investigational Site Number : 1240002
Toronto, Ontario, M5G 2M9, Canada
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Investigational Site Number : 1560001
Shanghai, 200120, China
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Investigational Site Number : 1560002
Wuhan, 430022, China
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Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 06351, South Korea
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Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 05505, South Korea
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Investigational Site Number : 7020001
Singapore, 308433, Singapore
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Investigational Site Number : 7020002
Singapore, 119074, Singapore
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Investigational Site Number : 7020003
Singapore, 169610, Singapore
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Lifespan Corporation- Site Number : 8400002
Providence, Rhode Island, 02903, United States
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The University of Texas MD Anderson Cancer Center- Site Number : 8400003
Houston, Texas, 77030, United States
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USC Norris Comprehensive Cancer Center- Site Number : 8400004
Los Angeles, California, 90033, United States
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