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En undersøgelse, der undersøger BGB-26808 alene eller i kombination med Tislelizumab hos deltagere med avancerede solide tumorer

24. september 2026 opdateret af: BeOne Medicines

Et fase 1-studie, der undersøger sikkerhed, tolerabilitet, farmakokinetik og foreløbig antitumoraktivitet af HPK1-hæmmer BGB-26808 alene eller i kombination med anti-PD-1 monoklonalt antistof Tislelizumab hos patienter med avancerede solide tumorer

This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

337

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Miranda, New South Wales, Australien, NSW 2228
        • Afsluttet
        • Southside Cancer Care
      • North Ryde, New South Wales, Australien, NSW 2109
        • Aktiv, ikke rekrutterende
        • Macquarie University
    • South Australia
      • Kurralta Park, South Australia, Australien, SA 5037
        • Aktiv, ikke rekrutterende
        • Icon Cancer Centre Kurralta Park
    • Western Australia
      • Nedlands, Western Australia, Australien, WA 6009
        • Afsluttet
        • Linear Clinical Research
  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010-3012
        • Rekruttering
        • City of Hope National Medical Center
      • Los Angeles, California, Forenede Stater, 90033
        • Rekruttering
        • University of Southern California Norris Comprehensive
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520-8028
        • Rekruttering
        • Yale University Yale Cancer Center
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Rekruttering
        • Sylvester Cancer Center, University of Miami
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-5316
        • Rekruttering
        • University of Michigan Health System
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Rekruttering
        • John Theurer Cancer Center Hackensack University Medical Center
    • New York
      • New York, New York, Forenede Stater, 10029-6504
        • Rekruttering
        • Icahn School of Medicine At Mount Sinai
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213-2933
        • Afsluttet
        • Providence Portland Medical Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030-4009
        • Rekruttering
        • The University of Texas Md Anderson Cancer Center
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230022
        • Rekruttering
        • The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150000
        • Rekruttering
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Kina, 430079
        • Rekruttering
        • Hubei Cancer Hospital
      • Wuhan, Hubei, Kina, 430101
        • Rekruttering
        • Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
    • Liaoning
      • Shenyang, Liaoning, Kina, 110167
        • Rekruttering
        • The First Hospital of China Medical University Hunnan Branch
    • Shandong
      • Jining, Shandong, Kina, 272000
        • Rekruttering
        • Jining No1 Peoples Hospital West Branch
      • Yantai, Shandong, Kina, 264000
        • Rekruttering
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200123
        • Rekruttering
        • Shanghai East Hospital Branch Hospital
      • Shanghai, Shanghai Municipality, Kina, 200433
        • Afsluttet
        • Shanghai Pulmonary Hospital
    • Sichuan
      • Chengdu, Sichuan, Kina, 610071
        • Rekruttering
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310006
        • Rekruttering
        • Hangzhou First Peoples Hospital
      • Taizhou, Zhejiang, Kina, 317004
        • Afsluttet
        • Taizhou Hospital of Zhejiang Province (East)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Rekruttering
        • Auckland City Hospital
      • Auckland, New Zealand, 1023
        • Rekruttering
        • Harbour Cancer and Wellness
      • Rotorua, New Zealand, 3010
        • Rekruttering
        • Health New Zealand Te Whatu Ora Lakes Rotorua Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
  4. Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
  5. ≥ 1 measurable lesion per RECIST v1.1.
  6. Able to provide an archived tumor tissue sample.
  7. Adequate organ function.
  8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for up to ≥ 270 days after the last dose of chemotherapy.
  9. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.

Exclusion Criteria:

  1. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
  3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
  4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse
  6. Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  7. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment(s).
  8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
  9. Uncontrolled diabetes.
  10. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phase 1a: Dose Escalation

Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
Medicin: BGB-26808

Planned doses administered orally as a tablet daily.

Medicin: Tislelizumab

Planned doses administered by intravenous infusion.

Andre navne:
  • BGB-A317
Eksperimentel: Phase 1b: Dose Expansion

Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.
Medicin: BGB-26808

Planned doses administered orally as a tablet daily.

Medicin: Tislelizumab

Planned doses administered by intravenous infusion.

Andre navne:
  • BGB-A317
Medicin: Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
Tidsramme: Approximately 1 month

MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
Tidsramme: Approximately 1 month

RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
Approximately 1 month
Phase 1b: Overall Response Rate (ORR)
Tidsramme: Approximately 6 months

ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Approximately 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 1a and 1b: Plasma concentrations of BGB-26808
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
Tidsramme: Approximately 1 month
Approximately 1 month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
Tidsramme: Approximately 1 month
Approximately 1 month
Phase 1a: ORR
Tidsramme: Approximately 6 months

ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Approximately 6 months
Phase 1a and 1b: Duration of Response (DOR)
Tidsramme: Approximately 9 months

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 as assessed by the investigator.
Approximately 9 months
Phase 1a and 1b: Disease Control Rate (DCR)
Tidsramme: Approximately 6 months

DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.
Approximately 6 months
Phase 1a and 1b: Clinical Benefit Rate (CBR)
Tidsramme: Approximately 6 months

CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.
Approximately 6 months
Phase 1b: Progression Free Survival (PFS)
Tidsramme: Approximately 9 months

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 assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Approximately 9 months
Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
Tidsramme: Approximately 1 month

Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.
Approximately 1 month
Phase 1b: Number of Participants with AEs and SAEs
Tidsramme: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

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)

21. september 2023

Primær færdiggørelse (Anslået)

28. februar 2029

Studieafslutning (Anslået)

28. februar 2029

Datoer for studieregistrering

Først indsendt

31. juli 2023

Først indsendt, der opfyldte QC-kriterier

31. juli 2023

Først opslået (Faktiske)

8. august 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BGB-A317-26808-101
  • CTR20240210 (Anden identifikator: ChinaDrugTrials)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD-delingstidsramme

See plan description

IPD-delingsadgangskriterier

See plan description

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

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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