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

16 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Trial Transparency email recommended (Toll free for US & Canada)
  • Numero di telefono: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Luoghi di studio

      • Shanghai, Cina, 200131
        • Reclutamento
        • Investigational Site Number : 1560001

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SAR445877 dose 1
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Sperimentale: SAR445877 dose 2
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective response rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
maximum serum concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2026

Completamento primario (Stimato)

2 agosto 2028

Completamento dello studio (Stimato)

2 agosto 2028

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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