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Een First-in-Human-studie van BG-C0979 bij volwassenen met gevorderde solide tumoren

24 september 2026 bijgewerkt door: BeOne Medicines

Een multicenter, open-label, fase 1a/b eerste-in-mensstudie om de veiligheid, verdraagbaarheid, farmacokinetiek en eerste antitumoractiviteit van BG-C0979 te onderzoeken bij patiënten met geselecteerde gevorderde solide tumoren

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

84

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
      • Frenchs Forest, New South Wales, Australië, NSW 2086
        • Werving
        • Northern Beaches Hospital
      • Liverpool, New South Wales, Australië, NSW 2170
        • Werving
        • Liverpool Hospital
    • Queensland
      • South Brisbane, Queensland, Australië, QLD 4101
        • Werving
        • Icon Cancer Centre South Brisbane
    • Victoria
      • Malvern, Victoria, Australië, VIC 3144
        • Werving
        • Cabrini Hospital Malvern
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Werving
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Werving
        • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
    • Fujian
      • Fuzhou, Fujian, China, 350028
        • Werving
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510245
        • Werving
        • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
    • Hubei
      • Yichang, Hubei, China, 443003
        • Werving
        • Yichang Central Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Werving
        • Fudan University Shanghai Cancer Centerpudong
  • Spanje
      • Barcelona, Spanje, 08036
        • Werving
        • Hospital Clinic de Barcelona
      • Barcelona, Spanje, 08035
        • Werving
        • Hospital Universitario Vall Dhebron
      • Madrid, Spanje, 28040
        • Werving
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spanje, 28223
        • Werving
        • Next Oncology Madrid
  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215-5418
        • Werving
        • Dana Farber Cancer Institute
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110-1010
        • Werving
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Werving
        • John Theurer Cancer Center Hackensack University Medical Center
    • Texas
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • Next Oncology San Antonio

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:

  • Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
  • Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
  • Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
  • Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
  • Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participants must have adequate organ function.

Exclusion Criteria:

  • Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

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: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

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

Participants will receive increasing doses of BG-C0979 as monotherapy.
Geneesmiddel: BG-C0979

Administered by intravenous infusion.
Experimenteel: Phase 1a: Monotherapy Safety Expansion

Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion.
Geneesmiddel: BG-C0979

Administered by intravenous infusion.
Experimenteel: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion

Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a.
Geneesmiddel: BG-C0979

Administered by intravenous infusion.
Experimenteel: Phase 1b, Part B: Combination Therapy Expansion

Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.
Geneesmiddel: BG-C0979

Administered by intravenous infusion.

Geneesmiddel: Tislelizumab

Administered by intravenous infusion.

Andere namen:
  • BGB-A317

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Tijdsspanne: Up to approximately 24 months

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results.
Up to approximately 24 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
Tijdsspanne: Up to approximately 10 months

MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
Up to approximately 10 months
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
Tijdsspanne: Up to approximately 10 months

The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available.
Up to approximately 10 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
Tijdsspanne: Up to approximately 24 months

RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available.
Up to approximately 24 months
Phase 1b: Overall Response Rate (ORR)
Tijdsspanne: Up to approximately 24 months

ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).
Up to approximately 24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fase 1a: Plasma Concentratie van BG-C0979
Tijdsspanne: Tot ongeveer 3 maanden
Tot ongeveer 3 maanden
Fase 1a: Oppervlakte onder de concentratie-tijdcurve (AUC) voor BG-C0979
Tijdsspanne: Tot ongeveer 3 maanden
Tot ongeveer 3 maanden
Fase 1a: Maximale waargenomen concentratie (Cmax) van BG-C0979
Tijdsspanne: Tot ongeveer 3 maanden
Tot ongeveer 3 maanden
Fase 1a: Tijd tot maximale concentratie (Tmax) van BG-C0979
Tijdsspanne: Tot ongeveer 3 maanden
Tot ongeveer 3 maanden
Fase 1b: Plasmaconcentratie van BG-C0979, alleen en in combinatie met Tislelizumab
Tijdsspanne: Tot ongeveer 3 maanden
Tot ongeveer 3 maanden
Phase 1a: ORR
Tijdsspanne: Up to approximately 24 months

ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).
Up to approximately 24 months
Phase 1a and 1b: Duration of Response (DOR)
Tijdsspanne: Up to approximately 24 months

DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.
Up to approximately 24 months
Phase 1a and 1b: Disease Control Rate (DCR)
Tijdsspanne: Up to approximately 24 months

DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease.
Up to approximately 24 months
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Tijdsspanne: Up to approximately 24 months

Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results.
Up to approximately 24 months
Phase 1b: Progression-Free Survival
Tijdsspanne: Up to approximately 24 months

PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.
Up to approximately 24 months
Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC
Tijdsspanne: Up to approximately 24 months

rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first.
Up to approximately 24 months
Prostate-Specific Antigen (PSA) Response for Participants with CRPC
Tijdsspanne: Up to approximately 24 months

PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.
Up to approximately 24 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)

13 april 2026

Primaire voltooiing (Geschat)

30 april 2029

Studie voltooiing (Geschat)

30 april 2029

Studieregistratiedata

Eerst ingediend

11 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 februari 2026

Eerst geplaatst (Werkelijk)

17 februari 2026

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

  • BG-C0979-101
  • 2025-524857-15-00 (Ctis)
  • CTR20261327 (Andere identificatie: ChinaDrugTrials)
  • 2025 (Subsidie/contract van de Amerikaanse NIH)

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 .

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