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A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer

16. juli 2026 opdateret af: Sanofi

A Phase 2, Open-label, Dose Optimization/Expansion Study of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Gastric or Gastroesophageal Junction Cancer

This is a Phase 2, open-label, dose optimization/expansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)/Gastroesophageal Junction cancer (GEJ). Participants with advanced GC/GEJ who relapsed to at least 1 prior regimen which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care, regardless combined positivity score (CPS) will be randomized in this study.

In this study, SAR445877 will be assessed as a monotherapy in approximately 30 participants with advanced unresectable or metastatic GC or Siewert Type 2 and 3 GEJ, and for whom receiving the standard of care (SOC) is not in his or her best interest, or where no SOC is established. Human epidermal growth factor receptor 2 (HER2) positive cases will not be eligible unless they have progressed on a HER2 targeted therapy. Those participants should have received at least 1 prior line of anti-cancer treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care. Metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases are not eligible.

Studieoversigt

Status

Rekruttering

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-mail: contact-us@sanofi.com

Studiesteder

      • Shanghai, Kina, 200131
        • Rekruttering
        • Investigational Site Number : 1560001

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Age

- Participant must be at least 18 years of age inclusive (or country's legal age of majority if >18 years), at the time of signing the informed consent.

Cancer diagnosis:

  • Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.
  • Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.

Prior anticancer therapy:

- Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1/PD-L1-based treatment or anti-Claudin 18.2 based treatment depending on local standard of care.

Measurable Disease:

- At least 1 measurable lesion per RECIST 1.1 criteria.

Exclusion Criteria:

Medical conditions

  • Eastern Cooperative Oncology Group(ECOG)performance status of ≥2.
  • Predicted life expectancy ≤3 months.
  • Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment.
  • Active brain metastases or leptomeningeal metastases.
  • Known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumor.
  • History of 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, or have not resolved to Grade ≤1.
  • Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine.
  • Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration.
  • Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related AEs (irAEs).
  • Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.
  • Organ transplant requiring immunosuppressive treatment.
  • Uncontrolled or active infection with human immunodeficiency virus (HIV ), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency.

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SAR445877 dose 1
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Eksperimentel: SAR445877 dose 2
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate
Tidsramme: From baseline to the end of study, up to approximately 2 years
Objective response rate, which is defined as the proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
From baseline to the end of study, up to approximately 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
maximum serum concentration (Cmax)
Tidsramme: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
time to maximum concentration (tmax)
Tidsramme: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
area under the concentration-time curve over dosing interval (AUCtau)
Tidsramme: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
End of infusion serum concentration (Cend of infusion)
Tidsramme: at Cycle 1 Day 1and Cycle 3 Day 1(Each cycle is 14 days)
at Cycle 1 Day 1and Cycle 3 Day 1(Each cycle is 14 days)
Percentage of participants with presence of anti-drug antibodies (ADA) against SAR445877
Tidsramme: From the first dose of Cycle 1 to 30 days after last dose of study interventions
From the first dose of Cycle 1 to 30 days after last dose of study interventions
Time to response (TTR)
Tidsramme: From baseline to the end of study, up to approximately 2 years
Time to response (TTR), defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed partial response (PR) or complete response (CR) determined by Investigator per RECIST v1.1
From baseline to the end of study, up to approximately 2 years
Duration of response (DOR)
Tidsramme: From baseline to the end of study, up to approximately 2 years
Duration of response (DOR), defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first
From baseline to the end of study, up to approximately 2 years
Clinical benefit rate
Tidsramme: From baseline to the end of study, up to approximately 2 years
Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST v1.1
From baseline to the end of study, up to approximately 2 years
Progression-free survival (PFS)
Tidsramme: From baseline to the end of study, up to approximately 2 years
Progression-free survival (PFS), defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST v1.1 or death from any cause, whichever occurs first
From baseline to the end of study, up to approximately 2 years
Overall survival (OS)
Tidsramme: From baseline to the end of study, up to approximately 2 years
Overall survival (OS), defined as the time from the first dose of IMP to the date of death due to any cause
From baseline to the end of study, up to approximately 2 years
Number of participants with presence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Tidsramme: The time from the first dose of study interventions up to 30 days after last dose of study interventions
The time from the first dose of study interventions up to 30 days after last dose of study interventions

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

2. august 2028

Studieafslutning (Anslået)

2. august 2028

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mavekræft

Kliniske forsøg med SAR445877

3
Abonner