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En førstegangsstudie på mennesker med BG-C0979 hos voksne med avanserte solide svulster

24. september 2026 oppdatert av: BeOne Medicines

Et multicentrisk, åpent merket, fase 1a/b først-på-mennesker-studie for å undersøke sikkerheten, toleransen, farmakokinetikken og den foreløpige antikreftaktiviteten til BG-C0979 hos pasienter med utvalgte avanserte solide svulster

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Phase 1a: Monotherapy Dose Escalation

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

Administered by intravenous infusion.
Eksperimentell: 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.
Legemiddel: BG-C0979

Administered by intravenous infusion.
Eksperimentell: 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.
Legemiddel: BG-C0979

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

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

Administered by intravenous infusion.

Legemiddel: Tislelizumab

Administered by intravenous infusion.

Andre navn:
  • BGB-A317

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Tidsramme: 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
Tidsramme: 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])
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fase 1a: Plasmakonsentrasjon av BG-C0979
Tidsramme: Opptil omtrent 3 måneder
Opptil omtrent 3 måneder
Fase 1a: Areal under konsentrasjon-tid-kurven (AUC) for BG-C0979
Tidsramme: Opptil omtrent 3 måneder
Opptil omtrent 3 måneder
Fase 1a: Maksimal observert konsentrasjon (Cmax) av BG-C0979
Tidsramme: Opptil omtrent 3 måneder
Opptil omtrent 3 måneder
Fase 1a: Tid til maksimal konsentrasjon (Tmax) av BG-C0979
Tidsramme: Opptil omtrent 3 måneder
Opptil omtrent 3 måneder
Fase 1b: Plasmakoncentration av BG-C0979, alene og i kombinasjon med Tislelizumab
Tidsramme: Opptil omtrent 3 måneder
Opptil omtrent 3 måneder
Phase 1a: ORR
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

BeOne Medicines

Etterforskere

  • Studieleder: Study Director, BeOne Medicines

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. april 2026

Primær fullføring (Antatt)

30. april 2029

Studiet fullført (Antatt)

30. april 2029

Datoer for studieregistrering

Først innsendt

11. februar 2026

Først innsendt som oppfylte QC-kriteriene

11. februar 2026

Først lagt ut (Faktiske)

17. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BG-C0979-101
  • 2025-524857-15-00 (Ctis)
  • CTR20261327 (Annen identifikator: ChinaDrugTrials)
  • 2025 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

See plan description

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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