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Et fase 1-studie af BGB-B2033, alene eller i kombination med Tislelizumab, hos deltagere med avancerede eller metastatiske solide tumorer

14. september 2026 opdateret af: BeOne Medicines

Et fase 1-studie, der undersøger sikkerhed, tolerabilitet, farmakokinetik, farmakodynamik og foreløbig antitumoraktivitet af BGB-B2033, alene eller i kombination med Tislelizumab, hos deltagere med udvalgte avancerede eller metastatiske solide tumorer

Dette studie er et første-i-menneske (FIH) fase 1-studie af BGB-B2033 for at vurdere sikkerhed, tolerabilitet, farmakokinetik (PK), farmakodynamik og foreløbig antitumoraktivitet af BGB-B2033 hos deltagere med fremskreden eller metastatisk hepatocellulært karcinom (HCC), alfa-føtoprotein (AFP)-producerende gastrisk cancer (GC), ekstragonadale blommesæktumorer, ikke-dysgerminomer eller glypican-3 (GPC3)-positiv planocellulær ikke-småcellet lungekræft (NSCLC). Studiet vil også identificere den anbefalede fase 2-dosis (RP2D) af BGB-B2033 alene og i kombination med tislelizumab til efterfølgende proof-of-concept undersøgelser. BGB-B2033 vil blive administreret ved intravenøs infusion. Fase 1-studiet vil blive udført i 2 dele: Del A (Monoterapi-dosiseskalering og sikkerhedsudvidelse) og del B (Kombinationsdosiseskalering og sikkerhedsudvidelse).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

630

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Brasilien
      • Barretos, Brasilien, 14.784-400
        • Rekruttering
        • Fundacao Pio Xii Hospital de Amor de Barretos
      • Porto Alegre, Brasilien, 90110-270
        • Rekruttering
        • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
      • Salvador, Brasilien, 41810-011
        • Rekruttering
        • Hospital Da Bahia
      • São José do Rio Preto, Brasilien, 15090-000
        • Rekruttering
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
      • São Paulo, Brasilien, 01246-000
        • Rekruttering
        • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-0004
        • Rekruttering
        • University of Alabama At Birmingham Hospital
    • Arizona
      • Goodyear, Arizona, Forenede Stater, 85338
        • Rekruttering
        • City of Hope Phoenix Cancer Center
    • California
      • Duarte, California, Forenede Stater, 91010-3012
        • Rekruttering
        • City of Hope National Medical Center
    • Illinois
      • Zion, Illinois, Forenede Stater, 60099
        • Rekruttering
        • City of Hope Chicago Cancer Center
    • New York
      • New York, New York, Forenede Stater, 10065-6800
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center Mskcc
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232-1309
        • Rekruttering
        • Upmc Hillman Cancer Center(Univ of Pittsburgh)
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203-1503
        • Rekruttering
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, Forenede Stater, 77030-4009
        • Rekruttering
        • The University of Texas MD Anderson Cancer Center
  • Frankrig
      • Clichy, Frankrig, 92110
        • Rekruttering
        • Hopital Beaujon
      • Nantes, Frankrig, 44000
        • Rekruttering
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Villejuif, Frankrig, 94800
        • Rekruttering
        • Institut Gustave Roussy
  • Italien
      • Naples, Italien, 80131
        • Rekruttering
        • Irccs Istituto Nazionale Tumori Fondazione Pascale
      • Padova, Italien, 35128
        • Rekruttering
        • Iov Istituto Oncologico Veneto Irccs
      • Roma, Italien, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Rozzano, Italien, 20089
        • Rekruttering
        • Irccs Humanitas Research Hospital
  • Japan
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Rekruttering
        • Kindai University Hospital
    • Tokyo
      • Bunkyoku, Tokyo, Japan, 113-8677
        • Rekruttering
        • Tokyo Metropolitan Komagome Hospital
      • Kotoku, Tokyo, Japan, 135-8550
        • Rekruttering
        • Cancer Institute Hospital of JFCR
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230000
        • Rekruttering
        • Anhui Provincial Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400030
        • Rekruttering
        • Chongqing University Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, Kina, 350028
        • Rekruttering
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, Kina, 510000
        • Rekruttering
        • ZhuJiang Hospital of Southern Medical University
    • Guangxi
      • Nanning, Guangxi, Kina, 530201
        • Rekruttering
        • Guangxi Medical University Cancer Hospital Wuxiang Branch
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050011
        • Rekruttering
        • The Fourth Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150000
        • Rekruttering
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Rekruttering
        • Hunan Cancer Hospital
    • Jiangsu
      • Xuzhou, Jiangsu, Kina, 221000
        • Rekruttering
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Rekruttering
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, Kina, 330038
        • Rekruttering
        • The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Rekruttering
        • Sichuan Cancer Hospital and Institute
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Rekruttering
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Lishui, Zhejiang, Kina, 323000
        • Rekruttering
        • Lishui Central Hospital
      • Wenzhou, Zhejiang, Kina, 325000
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
  • New Zealand
      • Auckland, New Zealand, 1023
        • Rekruttering
        • Auckland City Hospital
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Rekruttering
        • Hospital Oncologico
  • Sydkorea
    • Chungcheongbukdo
      • Cheongju-si, Chungcheongbukdo, Sydkorea, 28644
        • Rekruttering
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • BundangGu SeongnamSi, Gyeonggi-do, Sydkorea, 13496
        • Rekruttering
        • CHA Bundang Medical Center, CHA University
      • Seongnam-si, Gyeonggi-do, Sydkorea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
    • Seoul Teugbyeolsi
      • GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
        • Rekruttering
        • Samsung Medical Center
      • GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
        • Aktiv, ikke rekrutterende
        • Samsung Medical Center
      • SeodaemunGu, Seoul Teugbyeolsi, Sydkorea, 03722
        • Rekruttering
        • Severance Hospital Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
      • SongpaGu, Seoul Teugbyeolsi, Sydkorea, 05505
        • Rekruttering
        • Asan Medical Center

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

Inklusionskriterier:

  1. Kunne give et underskrevet og dateret skriftligt informeret samtykke forud for undersøgelsesspecifikke procedurer, prøveudtagning eller dataindsamling.
  2. Alder ≥ 18 år på dagen for underskrivelse af ICF (eller den lovlige lavalder i den jurisdiktion, hvor undersøgelsen finder sted, alt efter hvad der er ældre).

  3. Deltagere med en af ​​følgende uoperable lokalt fremskredne eller metastatiske tumortyper:

    1. HCC
    2. Histologisk bekræftet AFP-producerende GC (serum AFP > 20 ng/ml eller tumorvæv AFP positiv ved et valideret IHC assay i henhold til lokale testkriterier)
    3. Histologisk bekræftet kimcelletumor inklusive ekstragonadale blommesæktumorer lokaliseret i mediastinum, vagina, hjerne og retroperitoneum osv.) og ikke-dysgerminomer
    4. Histologisk bekræftet GPC3-positiv planocellulært NSCLC
  4. ≥ 1 evaluerbar læsion til dosiseskalering og ≥ 1 målbar læsion til sikkerhedsudvidelse, pr. RECIST v1.1
  5. ECOG Performance Status score ≤ 1

Ekskluderingskriterier:

  1. Tidligere behandling rettet mod glypican-3 (GPC3) eller den T-celle costimulerende receptor 4-1BB (også kendt som CD137)
  2. Aktiv leptomeningeal sygdom eller ukontrolleret, ubehandlet hjernemetastase
  3. Aktive autoimmune sygdomme eller historie med autoimmune sygdomme, der kan komme tilbage
  4. Enhver malignitet ≤ 2 år før den/de første dosis af forsøgslægemidler undtagen den specifikke cancer, der undersøges i denne undersøgelse og enhver lokalt tilbagevendende cancer, der er blevet behandlet med helbredende hensigter
  5. Enhver tilstand, der krævede systemisk behandling med enten kortikosteroider (> 10 mg dagligt prednison eller tilsvarende) eller anden immunsuppressiv medicin ≤ 14 dage før den første dosis af forsøgslægemidler.

Bemærk: Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende.

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: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part B (Triplet and Doublet Safety Expansion)
Safety expansion arm for each combination therapy cohort (triplet and doublet)
Medicin: Tislelizumab
Indgives ved intravenøs infusion
Medicin: BGB-B2033
Indgives ved intravenøs infusion
Medicin: Bevacizumab
Administreres ved intravenøs infusion
Eksperimentel: Part A (Monotherapy Dose Escalation and Safety Expansion)
Participants will receive ascending dose levels of BGB-B2033 monotherapy
Medicin: BGB-B2033
Indgives ved intravenøs infusion
Eksperimentel: Part B (Doublet Run-in)
Participants will receive BGB-B2033 in combination with tislelizumab and to inform the starting dose of BGB-B2033 for subsequent triplet dose escalation.
Medicin: Tislelizumab
Indgives ved intravenøs infusion
Medicin: BGB-B2033
Indgives ved intravenøs infusion
Eksperimentel: Part B (Triplet Dose Escalation)
Participants will receive BGB-B2033 in combination with tislelizumab and bevacizumab to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDFE) of the combination.
Medicin: Tislelizumab
Indgives ved intravenøs infusion
Medicin: BGB-B2033
Indgives ved intravenøs infusion
Medicin: Bevacizumab
Administreres ved intravenøs infusion
Eksperimentel: Part C (Asia Monotherapy Dose Expansion in HCC)
Participants in Asian countries with HCC will receive BGB-B2033 as monotherapy.
Medicin: BGB-B2033
Indgives ved intravenøs infusion
Eksperimentel: Part D (US Monotherapy Dose Expansion in HCC)
Participants in the United States (US) with HCC will receive BGB-B2033 as monotherapy.
Medicin: BGB-B2033
Indgives ved intravenøs infusion
Eksperimentel: Part E (Monotherapy Dose Expansion in HCC)
Participants with HCC will receive BGB-B2033 as monotherapy.
Medicin: BGB-B2033
Indgives ved intravenøs infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to approximately 2 years
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy [ASTCT] for cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to approximately 2 years
Part A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033
Tidsramme: Up to approximately 2 years
The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.
Up to approximately 2 years
Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033
Tidsramme: Up to approximately 2 years
The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration
Up to approximately 2 years
Parts C, D, and E: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Tidsramme: Up to approximately 2 years
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Up to approximately 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A and B: Overall Response Rate (ORR) as assessed by the investigator
Tidsramme: Up to approximately 2 years
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Up to approximately 2 years
Part A and B: Duration of Response (DOR) as assessed by the investigator
Tidsramme: Up to approximately 2 years
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first.
Up to approximately 2 years
Part A and B: Disease Control Rate (DCR) as assessed by the investigator
Tidsramme: Up to approximately 2 years
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments using RECIST v1.1.
Up to approximately 2 years
Part A and B: Progression Free Survival (PFS) as assessed by the investigator
Tidsramme: Up to approximately 2 years
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease using RECIST v1.1 or death due to any cause, whichever occurs first.
Up to approximately 2 years
Part A and B: Serum concentration of of BGB-B2033
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
Part A and B: Number of participants with anti-drug antibodies (ADAs) to BGB-B2033
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
Parts C, D, and E: Overall Response Rate (ORR) as assessed by the Investigator
Tidsramme: Up to approximately 2 years
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Up to approximately 2 years
Parts C, D, and E: Duration of Response (DOR) as assessed by the investigator and IRC
Tidsramme: Up to approximately 2 years
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first.
Up to approximately 2 years
Parts C, D, and E: Progression Free Survival (PFS) as assessed by the investigator and IRC
Tidsramme: Up to approximately 2 years
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease using RECIST v1.1 or death due to any cause, whichever occurs first.
Up to approximately 2 years
All Parts: Overall Survival (OS)
Tidsramme: Up to approximately 2 years
OS is defined as the time from first dose to the death due to any cause.
Up to approximately 2 years
Parts C, D, and E: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to approximately 2 years

Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs), characterized by type, frequency, and severity. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), and, where applicable, according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Events will also be described by timing of onset, seriousness, and assessed relationship to the study therapy. In addition, adverse events meeting protocol-defined adverse events of clinical interest (AECIs) will be specifically evaluated. Laboratory abnormalities will be summarized as part of the overall safety assessment.
Up to approximately 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

BeOne Medicines

Efterforskere

  • Studieleder: Study Director, BeOne Medicines

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)

23. juli 2024

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

31. oktober 2028

Datoer for studieregistrering

Først indsendt

20. maj 2024

Først indsendt, der opfyldte QC-kriterier

20. maj 2024

Først opslået (Faktiske)

24. maj 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BGB-B2033-101 (Chinadrugtrials)
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524136-19-00 (Ctis)
  • jRCT2051260010 (Anden identifikator: jRCT)
  • CTR20242917 (Registry Identifier: ChinaDrugTrials)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

BeOne deler data om afsluttede undersøgelser ansvarligt og giver kvalificerede videnskabelige og medicinske forskere adgang til data og understøttende dokumentation for kliniske forsøg i dossiers for lægemidler og indikationer efter indsendelse og godkendelse i USA, Kina og Europa. Kliniske forsøg, der understøtter efterfølgende lokale godkendelser, nye indikationer eller kombinationsprodukter, kommer i betragtning til deling, når de tilsvarende regulatoriske godkendelser er opnået.

BeOne deler kun data, når det er tilladt af gældende love og regler om databeskyttelse og -sikkerhed, når det er muligt at gøre det uden at kompromittere privatlivet for undersøgelsesdeltagerne og andre hensyn.

Kvalificerede forskere med passende kompetencer, der er engageret i ny videnskabelig forskning, kan indsende en anmodning om deltager-niveau data med en forskningsproposal til BeOne gennemgang. Forskningshold skal inkludere en biostatistiker og underskrive en Data Delingsaftale før adgang til kliniske forsøgsdata gives.

IPD-delingstidsramme

Se planbeskrivelse

IPD-delingsadgangskriterier

Se planbeskrivelse

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

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