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

2. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-Mail: Contact-US@sanofi.com

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: SAR445877 dose 1
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Experimental: SAR445877 dose 2
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective response rate
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
maximum serum concentration (Cmax)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

6. Juli 2026

Primärer Abschluss (Geschätzt)

2. August 2028

Studienabschluss (Geschätzt)

2. August 2028

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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