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Experimental cancer drug trial halted early

NCT ID NCT05450562

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

33 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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

    New York, New York, 10029, United States

  • Investigational Site Number : 1240001

    Québec, Quebec, G1R 2J6, Canada

  • Investigational Site Number : 1240002

    Toronto, Ontario, M5G 2M9, Canada

  • Investigational Site Number : 1560001

    Shanghai, 200120, China

  • Investigational Site Number : 1560002

    Wuhan, 430022, China

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 7020001

    Singapore, 308433, Singapore

  • Investigational Site Number : 7020002

    Singapore, 119074, Singapore

  • Investigational Site Number : 7020003

    Singapore, 169610, Singapore

  • Lifespan Corporation- Site Number : 8400002

    Providence, Rhode Island, 02903, United States

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

    Houston, Texas, 77030, United States

  • USC Norris Comprehensive Cancer Center- Site Number : 8400004

    Los Angeles, California, 90033, United States

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Other studies related to the condition(s) this trial covers.