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An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors

9 novembre 2026 aggiornato da: BeOne Medicines

Uno Studio di Fase 1a/1b che Valuta la Sicurezza, Tollerabilità, Farmacocinetica, Farmacodinamica e l'Attività Antitumorale Preliminare di BG-75202, da Solo e in Combinazione con Altri Agenti in Pazienti con Tumori Solidi Avanzati

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study will enroll participants with advanced or metastatic solid tumors, including breast cancer. Breast cancer is one of the most common cancers in women.

BG-75202 is an experimental drug that blocks proteins called KAT6A and 6B. These proteins are believed to help tumor growth in a number of cancers including certain types of breast cancer and other solid tumors. By blocking KAT6A and 6B, BG-75202 may be able to slow down or stop the growth of tumor cells.

This study consists of 2 parts, one called dose escalation and safety expansion and the other called dose optimization and dose expansion.

During the dose escalation and safety expansion part, the study doctors will test different doses of the study drug. This part of the study will evaluate BG-75202 alone (monotherapy) and combined with another drug (combination therapy).

During the dose optimization and dose expansion part, the study doctors will test the study drug in a larger number of people using the dose(s) identified from dose escalation and safety expansion. In this part of the study, BG-75202 will be taken with 1 or 2 other drugs.

The study will enroll participants with advanced or metastatic solid tumors at multiple centers worldwide.

The overall time to participate in this study may be up to approximately five years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.

Tipo di studio

Interventistico

Iscrizione (Stimato)

186

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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, Part 2A, 2B, and SE Parts 1A and 1B (except Food Effect): 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 1 line of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload) in the advanced/metastatic setting.
  • Food Effect only in SE Parts 1A or 1B: Patients with histologically or cytologically confirmed advanced, metastatic breast cancer who have exhausted, are intolerant of all available standard-of-care therapies, and/or without available standard-of-care therapies.
  • Parts 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy

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

Administered orally.
Sperimentale: 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.
Droga: BG-75202

Administered orally.

Droga: Estrogen Receptor Antagonist

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

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

Administered orally.

Droga: Estrogen Receptor Antagonist

Administered by intramuscular injection.
Sperimentale: 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.
Droga: BG-75202

Administered orally.

Droga: CDK4 Inhibitor

Administered orally.

Droga: Aromatase Inhibitor

Administered orally.
Sperimentale: Part 2B: Safety Lead-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.
Droga: BG-75202

Administered orally.

Droga: CDK4 Inhibitor

Administered orally.

Droga: Aromatase Inhibitor

Administered orally.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1 and Part 2B (Safety Lead-in): Number of Participants with Adverse Events (AEs)
Lasso di tempo: 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 and Part 2B (Safety Lead-in): Recommended Dose for Expansion (RDFE)
Lasso di tempo: 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 A and Part 2C: Overall Response Rate (ORR)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parti 1 e 2: Concentrazione plasmatica massima osservata (Cmax) di BG-75202
Lasso di tempo: Fino a circa 4 mesi
Fino a circa 4 mesi
Parti 1 e 2: Concentrazione plasmatica minima osservata (Ctrough) di BG-75202
Lasso di tempo: Fino a circa 4 mesi
Fino a circa 4 mesi
Parti 1 e 2: Area Sotto la Curva Concentrazione-Tempo Plasmatica (AUC) di BG-75202
Lasso di tempo: Fino a circa 4 mesi
Fino a circa 4 mesi
Parte 1 e 2: Emivita terminale (t1/2) di BG-75202
Lasso di tempo: Fino a circa 4 mesi
Fino a circa 4 mesi
Part 1 and Part 2B (Safety Lead-in): ORR
Lasso di tempo: 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
Duration of Response (DOR)
Lasso di tempo: 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
Disease Control Rate (DCR)
Lasso di tempo: 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
Clinical Benefit Rate (CBR)
Lasso di tempo: 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: Time to Response (TTR)
Lasso di tempo: 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 2A and Part 2C: Progression-Free Survival (PFS)
Lasso di tempo: 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 2A and Part 2C: Number of Participants with Adverse Events (AEs)
Lasso di tempo: 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 2A and Part 2C: Recommended Phase 2 Dose (RP2D) or Recommended Phase 3 Dose (RP3D)
Lasso di tempo: Up to approximately 2 years

The RP2D or RP3D 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

BeOne Medicines

Investigatori

  • Direttore dello studio: Study Director, BeOne Medicines

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 dicembre 2025

Completamento primario (Stimato)

30 settembre 2029

Completamento dello studio (Stimato)

13 gennaio 2037

Date di iscrizione allo studio

Primo inviato

28 ottobre 2025

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2025

Primo Inserito (Effettivo)

29 ottobre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BG-75202-101
  • 2025-523553-34-00 (Ctis)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

See plan description

Criteri di accesso alla condivisione IPD

See plan description

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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