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Een studie waarin BGB-26808 alleen of in combinatie met Tislelizumab wordt onderzocht bij deelnemers met vergevorderde solide tumoren

24 september 2026 bijgewerkt door: BeOne Medicines

Een fase 1-onderzoek naar de veiligheid, verdraagbaarheid, farmacokinetiek en voorlopige antitumoractiviteit van HPK1-remmer BGB-26808 alleen of in combinatie met anti-PD-1 monoklonaal antilichaam Tislelizumab bij patiënten met vergevorderde solide tumoren

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

337

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Phase 1a: Dose Escalation

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

Planned doses administered orally as a tablet daily.

Geneesmiddel: Tislelizumab

Planned doses administered by intravenous infusion.

Andere namen:
  • BGB-A317
Experimenteel: Phase 1b: Dose Expansion

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

Planned doses administered orally as a tablet daily.

Geneesmiddel: Tislelizumab

Planned doses administered by intravenous infusion.

Andere namen:
  • BGB-A317
Geneesmiddel: Chemotherapy

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

BeOne Medicines

Onderzoekers

  • Studie directeur: Study Director, BeOne Medicines

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 september 2023

Primaire voltooiing (Geschat)

28 februari 2029

Studie voltooiing (Geschat)

28 februari 2029

Studieregistratiedata

Eerst ingediend

31 juli 2023

Eerst ingediend dat voldeed aan de QC-criteria

31 juli 2023

Eerst geplaatst (Werkelijk)

8 augustus 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BGB-A317-26808-101
  • CTR20240210 (Andere identificatie: ChinaDrugTrials)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

See plan description

IPD-toegangscriteria voor delen

See plan description

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren