Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies

10 settembre 2026 aggiornato da: BeOne Medicines

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BG-75202, Alone and in Combination With Other Agents, in Patients With Myeloid Malignancies

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of BG-75202 (KAT6A/B inhibitor) alone and in combination with other agents in patients with myeloid malignancies.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

118

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
      • Concord, New South Wales, Australia, NSW 2139
        • Reclutamento
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, NSW 2217
        • Reclutamento
        • St George Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, SA 5037
        • Reclutamento
        • Icon Cancer Centre Kurralta Park
    • Victoria
      • Heidelberg, Victoria, Australia, VIC 3084
        • Reclutamento
        • Austin Health
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Reclutamento
        • Linear Clinical Research
  • Cina
    • Gansu
      • Lanzhou, Gansu, Cina, 730000
        • Reclutamento
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510000
        • Reclutamento
        • ZhuJiang Hospital of Southern Medical University
    • Hebei
      • Shijiazhuang, Hebei, Cina, 050000
        • Reclutamento
        • The Second Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, Cina, 451161
        • Reclutamento
        • The First Affiliated Hospital of Zhengzhou Universitysouth Branch
    • Hubei
      • Wuhan, Hubei, Cina, 430030
        • Reclutamento
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Jiangsu
      • Suzhou, Jiangsu, Cina, 215006
        • Reclutamento
        • The First Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, Cina, 330006
        • Reclutamento
        • The First Affiliated Hospital of Nanchang University Branch Donghu
      • Nanchang, Jiangxi, Cina, 332000
        • Reclutamento
        • The First Affiliated Hospital of Nanchang University Branch Xianghu
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Cina, 301617
        • Reclutamento
        • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
  • Nuova Zelanda
      • Auckland, Nuova Zelanda, 1023
        • Reclutamento
        • Auckland City Hospital
      • Auckland, Nuova Zelanda, 0622
        • Reclutamento
        • North Shore Hospital

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the Informed consent form (ICF).

  • Patients must have a confirmed diagnosis of myeloid malignancies based on 2016 World Health Organization criteria, and meet the following categories:

    • Relapsed/refractory; myeloid malignancies after ≥1 prior systemic therapy, per ELN; 2022 criteria; patients with actionable genetic alteration must have previously received targeted therapies unless contraindicated, unavailable/inaccessible, or declined by patient.
  • Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion Criteria:

  • Prior exposure to KAT6A/B inhibitors/degraders.
  • A diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia.
  • Known central nervous system involvement by leukemia
  • Use of antileukemic therapies without sufficient washout period

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: Phase 1a: Part A: Dose escalation, BG-75202 monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Droga: BG-75202
Administered orally
Sperimentale: Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA)
Sequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated.
Droga: BG-75202
Administered orally
Droga: Hypomethylation Agent (HMA)
Administered Intravenous (IV) or Subcutaneous (SC)
Sperimentale: Phase 1b: Dose optimization, BG-75202 monotherapy
Participants will receive BG-75202 monotherapy
Droga: BG-75202
Administered orally

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not.

An SAE is any untoward medical occurrence that, at any dose,

  • Results in death
  • Is life-threatening
  • Requires hospitalization or prolongation of existing hospitalization
  • Results in disability/incapacity
  • Is congenital anomaly/birth defect
  • Is considered a significant medical AE by the investigator based on medical judgement
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months
Phase 1a: Recommended Dose for Expansion (RDFE) of BG-75202
Lasso di tempo: Estimated approximately 18 months
The potential RDFE(s) of BG-75202 as monotherapy or in combination with HMA are based upon 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 18 months
Phase 1b: Dose Optimization: Complete Remission (CR) Rate
Lasso di tempo: Up to approximately 12 months
CR rate is defined as the percentage of participants who achieved a best response of CR as assessed by investigator's review.
Up to approximately 12 months
Phase 1b: Dose Optimization: Complete Remission (CR) plus CR With Partial Hematologic Recovery (CRh) Rate
Lasso di tempo: Up to approximately 12 months
CR + CRh rate is defined as the percentage of participants who achieved the best response of CR or CRh as assessed by investigator's review.
Up to approximately 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1b Dose Optimization: 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 18 months
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not.
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 18 months
Phase 1b: Time to Response (TTR)
Lasso di tempo: Up to approximately 12 months
TTR for CR, CR + CRi, CR + CRh, and ORR, defined as the time from the randomization date, to the first determination of the respective objective response.
Up to approximately 12 months
Phase 1b: CR + Complete Remission with Incomplete Hematologic Recovery (CRi) Rate
Lasso di tempo: Up to approximately 12 months
CR + CRi rate is defined as the percentage of patients who achieved a best response of CR or CRi as assessed by investigator's review.
Up to approximately 12 months
Phase 1a: Dose Escalation: CR + CRh Rate
Lasso di tempo: Up to approximately 12 months
CR + CRh rate is defined as the percentage of patients who achieved a best response of CR or CRh as assessed by investigator's review.
Up to approximately 12 months
Phase 1a and Phase 1b: Overall response rate (ORR)
Lasso di tempo: Up to approximately 12 months
ORR is defined as the percentage of participants who achieved a best response of CR, CRh, CRi, or partial response (PR) as assessed by investigator's review.
Up to approximately 12 months
Phase 1b: Event Free Survival (EFS)
Lasso di tempo: Up to approximately 18 months
EFS, defined as the time from the randomization date for Phase 1b, to the date of first documentation of treatment failure per European LeukemiaNet (ELN) 2022 (refractory disease and relapsed disease) or death due to any cause, whichever occurs first.
Up to approximately 18 months
Phase 1b: Overall Survival (OS)
Lasso di tempo: Up to approximately 18 months
OS, defined as the time from the randomization date for Phase to the date of death due to any cause.
Up to approximately 18 months
Phase 1b: Transfusion Independence
Lasso di tempo: Up to approximately 12 months
Transfusion independence, defined as the proportion of patients who achieve red blood cell and/or platelet transfusion independence according to protocol specified criteria, among patients who are transfusion-dependent at baseline.
Up to approximately 12 months
Phase 1a and Phase 1b: Observed Plasma Maximum Concentration (Cmax) of BG-75202
Lasso di tempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Lasso di tempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202
Lasso di tempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202
Lasso di tempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
Lasso di tempo: Up to approximately 18 months
The RP2D of BG-75202 takes into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.
Up to approximately 18 months

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 Medicine

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)

23 giugno 2026

Completamento primario (Stimato)

30 settembre 2028

Completamento dello studio (Stimato)

30 settembre 2028

Date di iscrizione allo studio

Primo inviato

22 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • BG-75202-102

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 .

Sottoscrivi