Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een Onderzoeksstudie naar BG-75202 Alleen en in Combinatie met Andere Therapeutische Middelen bij Volwassenen met Geavanceerde Vaste Tumoren

24 september 2026 bijgewerkt door: BeOne Medicines

Een fase 1a/1b-studie die de veiligheid, verdraagbaarheid, farmacokinetiek, farmacodynamiek en voorlopige antitumoractiviteit van BG-75202 evalueert, alleen en in combinatie met andere middelen bij patiënten met gevorderde solide tumoren

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

86

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
      • Blacktown, New South Wales, Australië, NSW 2148
        • Werving
        • Blacktown Cancer and Haematology Centre
      • Camperdown, New South Wales, Australië, NSW 2050
        • Werving
        • Chris Obrien Lifehouse
    • South Australia
      • Adelaide, South Australia, Australië, SA 5000
        • Werving
        • Cancer Research South Australia
    • Victoria
      • Heidelberg, Victoria, Australië, VIC 3084
        • Werving
        • Austin Health
      • Melbourne, Victoria, Australië, VIC 3000
        • Werving
        • Peter Maccallum Cancer Centre
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Werving
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Werving
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Werving
        • Chongqing University Cancer Hospital
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Werving
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510555
        • Werving
        • Sun Yat Sen University Cancer Center Huangpu Branch
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Werving
        • Harbin Medical University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Werving
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210036
        • Werving
        • Jiangsu Province Hospital Longjiang Branch
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Werving
        • Fudan University Shanghai Cancer Centerpudong
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Werving
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Werving
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Italië
      • Milan, Italië, 20141
        • Werving
        • Istituto Europeo Di Oncologia
      • Naples, Italië, 80131
        • Werving
        • Istituto Nazionale Tumori Fondazione G Pascale
      • Roma, Italië, 00168
        • Werving
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Rozzano, Italië, 20089
        • Werving
        • Istituto Clinico Humanitas
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland, 1023
        • Werving
        • Auckland City Hospital
  • Spanje
      • Barcelona, Spanje, 08035
        • Werving
        • Hospital Universitario Vall Dhebron
      • Barcelona, Spanje, 8023
        • Werving
        • Next Oncology Barcelona
      • Madrid, Spanje, 28041
        • Werving
        • Hospital Universitario 12 de Octubre
      • Madrid, Spanje, 28240
        • Werving
        • Hospital Clinico San Carlos
      • Málaga, Spanje, 29010
        • Werving
        • Hospital Universitario Virgen de La Victoria
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35294-0004
        • Werving
        • University of Alabama At Birmingham Hospital
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Werving
        • Yale Cancer Center
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110-1010
        • Werving
        • Washington University in St Louis
    • Texas
      • Austin, Texas, Verenigde Staten, 78758
        • Werving
        • Next Oncology Austin
      • Houston, Texas, Verenigde Staten, 77030-4009
        • Werving
        • The University of Texas Md Anderson Cancer Center
    • Washington
      • Seattle, Washington, Verenigde Staten, 98109-4433
        • Werving
        • Fred Hutchinson Cancer Research 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:

  • Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies.
  • Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload).
  • Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.
  • Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
  • Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate organ function.

Exclusion Criteria:

  • Prior exposure to KAT6A/B or KAT7 inhibitors/degraders.
  • Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  • Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.

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: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Geneesmiddel: BG-75202

Administered orally.
Experimenteel: Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist.
Geneesmiddel: BG-75202

Administered orally.

Geneesmiddel: Estrogen Receptor Antagonist

Administered by intramuscular injection.
Experimenteel: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist

Participants will receive BG-75202 in combination with an estrogen receptor antagonist.
Geneesmiddel: BG-75202

Administered orally.

Geneesmiddel: Estrogen Receptor Antagonist

Administered by intramuscular injection.
Experimenteel: Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor

Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor.
Geneesmiddel: BG-75202

Administered orally.

Geneesmiddel: CDK4 Inhibitor

Administered orally.

Geneesmiddel: Aromatase Inhibitor

Administered orally.
Experimenteel: Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor

Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
Geneesmiddel: BG-75202

Administered orally.

Geneesmiddel: CDK4 Inhibitor

Administered orally.

Geneesmiddel: Aromatase Inhibitor

Administered orally.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: Number of Participants with Adverse Events (AEs)
Tijdsspanne: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
Part 1: Recommended Dose for Expansion (RDFE)
Tijdsspanne: Estimated approximately 1 year

The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data.
Estimated approximately 1 year
Part 2: Overall Response Rate (ORR)
Tijdsspanne: Up to approximately 2 years

ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Up to approximately 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Deel 1 en 2: Maximale waargenomen plasmaconcentratie (Cmax) van BG-75202
Tijdsspanne: Tot ongeveer 4 maanden
Tot ongeveer 4 maanden
Onderdeel 1 en 2: Minimum waargenomen plasmaconcentratie (Ctrough) van BG-75202
Tijdsspanne: Tot ongeveer 4 maanden
Tot ongeveer 4 maanden
Deel 1 en 2: Oppervlak onder de plasmaconcentratie-tijdcurve (AUC) van BG-75202
Tijdsspanne: Tot ongeveer 4 maanden
Tot ongeveer 4 maanden
Deel 1 en 2: Eindhalveringstijd (t1/2) van BG-75202
Tijdsspanne: Tot ongeveer 4 maanden
Tot ongeveer 4 maanden
Part 1: ORR
Tijdsspanne: Up to approximately 1 year

ORR is defined as the percentage of participants with partial response (PR) or complete response (CR), as assessed by the investigator using RECIST v1.1.
Up to approximately 1 year
Part 1: Duration of Response (DOR)
Tijdsspanne: Up to approximately 1 year

DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.
Up to approximately 1 year
Part 1: Time to Response (TTR)
Tijdsspanne: Up to approximately 1 year

TTR is defined as the time from treatment initiation to the first determination of objective response.
Up to approximately 1 year
Part 2: DOR
Tijdsspanne: Up to approximately 2 years

DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.
Up to approximately 2 years
Part 2: TTR
Tijdsspanne: Up to approximately 2 years

TTR is defined as the time from treatment initiation to the first determination of objective response.
Up to approximately 2 years
Part 2: Disease Control Rate (DCR)
Tijdsspanne: Up to approximately 2 years

DCR is defined as the percentage of participants who achieve CR, PR, or stable disease as assessed by investigator's review.
Up to approximately 2 years
Part 2: Clinical Benefit Rate (CBR)
Tijdsspanne: Up to approximately 2 years

CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks).
Up to approximately 2 years
Part 2: Progression-Free Survival (PFS)
Tijdsspanne: Up to approximately 2 years

PFS is defined as the time from the date of the first dose of study treatment(s) to the date of the first documentation of disease progression assessed by investigator's review or death, whichever occurs first.
Up to approximately 2 years
Part 2: Number of Participants with Adverse Events (AEs)
Tijdsspanne: Up to approximately 2 years

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, and laboratory values.
Up to approximately 2 years
Part 2: Recommended Phase 2 Dose (RP2D)
Tijdsspanne: Up to approximately 2 years

The RP2D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.
Up to approximately 2 years

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)

11 december 2025

Primaire voltooiing (Geschat)

30 september 2029

Studie voltooiing (Geschat)

13 januari 2037

Studieregistratiedata

Eerst ingediend

28 oktober 2025

Eerst ingediend dat voldeed aan de QC-criteria

28 oktober 2025

Eerst geplaatst (Werkelijk)

29 oktober 2025

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-75202-101
  • 2025-523553-34-00 (Ctis)
  • 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 .

Abonneren