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

10. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

118

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phase 1a: Part A: Dose escalation, BG-75202 monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Medicin: BG-75202
Administered orally
Eksperimentel: 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.
Medicin: BG-75202
Administered orally
Medicin: Hypomethylation Agent (HMA)
Administered Intravenous (IV) or Subcutaneous (SC)
Eksperimentel: Phase 1b: Dose optimization, BG-75202 monotherapy
Participants will receive BG-75202 monotherapy
Medicin: BG-75202
Administered orally

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Tidsramme: 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
Tidsramme: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202
Tidsramme: Up to approximately 5 months
Up to approximately 5 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BeOne Medicines

Efterforskere

  • Studieleder: Study Director, BeOne Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. juni 2026

Primær færdiggørelse (Anslået)

30. september 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BG-75202-102

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

IPD-delingsadgangskriterier

See plan description

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner