Tutkimuslääkekoe BG-75202:sta Yksin ja Yhdistettynä Muihin Hoitomuotoihin Aikuisilla, Joilla on Kehittyneet Kiinteät Syövät
Vaiheen 1a/1b tutkimus, jossa arvioidaan BG-75202:n turvallisuutta, siedettävyyttä, farmakokinetiikkaa, farmakodynamiikkaa ja alustavaa antikasvaintoimintaa yksinään ja yhdistelmässä muiden lääkeaineiden kanssa kehittyneisiin kiinteisiin kasvaimiin sairastuneilla potilailla
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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Study Director
- Puhelinnumero: 877-828-5568
- Sähköposti: clinicaltrials@beonemed.com
Opiskelupaikat
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Rekrytointi
- Blacktown Cancer and Haematology Centre
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Camperdown, New South Wales, Australia, NSW 2050
- Rekrytointi
- Chris Obrien Lifehouse
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South Australia
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Adelaide, South Australia, Australia, SA 5000
- Rekrytointi
- Cancer Research South Australia
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Victoria
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Heidelberg, Victoria, Australia, VIC 3084
- Rekrytointi
- Austin Health
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Melbourne, Victoria, Australia, VIC 3000
- Rekrytointi
- Peter Maccallum Cancer Centre
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Barcelona, Espanja, 08035
- Rekrytointi
- Hospital Universitario Vall Dhebron
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Barcelona, Espanja, 8023
- Rekrytointi
- Next Oncology Barcelona
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Madrid, Espanja, 28041
- Rekrytointi
- Hospital Universitario 12 de Octubre
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Madrid, Espanja, 28240
- Rekrytointi
- Hospital Clinico San Carlos
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Málaga, Espanja, 29010
- Rekrytointi
- Hospital Universitario Virgen de La Victoria
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Milan, Italia, 20141
- Rekrytointi
- Istituto Europeo Di Oncologia
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Naples, Italia, 80131
- Rekrytointi
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma, Italia, 00168
- Rekrytointi
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano, Italia, 20089
- Rekrytointi
- Istituto Clinico Humanitas
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100142
- Rekrytointi
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kiina, 100021
- Rekrytointi
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kiina, 400030
- Rekrytointi
- Chongqing University Cancer Hospital
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Fujian
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Xiamen, Fujian, Kiina, 361003
- Rekrytointi
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Kiina, 510555
- Rekrytointi
- Sun Yat Sen University Cancer Center Huangpu Branch
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Heilongjiang
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Harbin, Heilongjiang, Kiina, 150000
- Rekrytointi
- Harbin Medical University Cancer Hospital
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Hunan
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Changsha, Hunan, Kiina, 410013
- Rekrytointi
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, Kiina, 210036
- Rekrytointi
- Jiangsu Province Hospital Longjiang Branch
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 201321
- Rekrytointi
- Fudan University Shanghai Cancer Centerpudong
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kiina, 300060
- Rekrytointi
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kiina, 310016
- Rekrytointi
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Auckland, Uusi Seelanti, 1023
- Rekrytointi
- Auckland City Hospital
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35294-0004
- Rekrytointi
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven, Connecticut, Yhdysvallat, 06510
- Rekrytointi
- Yale Cancer Center
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Missouri
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St Louis, Missouri, Yhdysvallat, 63110-1010
- Rekrytointi
- Washington University in St Louis
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Texas
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Austin, Texas, Yhdysvallat, 78758
- Rekrytointi
- Next Oncology Austin
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Houston, Texas, Yhdysvallat, 77030-4009
- Rekrytointi
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle, Washington, Yhdysvallat, 98109-4433
- Rekrytointi
- Fred Hutchinson Cancer Research Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
Administered orally. |
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Kokeellinen: 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. |
Administered orally. Administered by intramuscular injection. |
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Kokeellinen: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist
Participants will receive BG-75202 in combination with an estrogen receptor antagonist. |
Administered orally. Administered by intramuscular injection. |
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Kokeellinen: 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. |
Administered orally. Administered orally. Administered orally. |
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Kokeellinen: 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. |
Administered orally. Administered orally. Administered orally. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Part 1: Number of Participants with Adverse Events (AEs)
Aikaikkuna: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
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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
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Part 1: Recommended Dose for Expansion (RDFE)
Aikaikkuna: Estimated approximately 1 year
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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
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Part 2: Overall Response Rate (ORR)
Aikaikkuna: Up to approximately 2 years
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Osat 1 ja 2: BG-75202:n suurin havaittu plasmapitoisuus (Cmax)
Aikaikkuna: Jopa noin 4 kuukautta
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Jopa noin 4 kuukautta
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Osat 1 ja 2: BG-75202:n havaittu vähimmäisplasmapitoisuus (Ctrough)
Aikaikkuna: Enintään noin 4 kuukautta
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Enintään noin 4 kuukautta
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Osat 1 ja 2: BG-75202:n plasmakoostumus-aikakäyrän alapuolinen pinta-ala (AUC)
Aikaikkuna: Jopa noin 4 kuukautta
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Jopa noin 4 kuukautta
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Osat 1 ja 2: BG-75202:n eliminaation puoliintumisaika (t1/2)
Aikaikkuna: Enintään noin 4 kuukautta
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Enintään noin 4 kuukautta
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Part 1: ORR
Aikaikkuna: Up to approximately 1 year
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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
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Part 1: Duration of Response (DOR)
Aikaikkuna: Up to approximately 1 year
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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
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Part 1: Time to Response (TTR)
Aikaikkuna: Up to approximately 1 year
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TTR is defined as the time from treatment initiation to the first determination of objective response. |
Up to approximately 1 year
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Part 2: DOR
Aikaikkuna: Up to approximately 2 years
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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
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Part 2: TTR
Aikaikkuna: Up to approximately 2 years
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TTR is defined as the time from treatment initiation to the first determination of objective response. |
Up to approximately 2 years
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Part 2: Disease Control Rate (DCR)
Aikaikkuna: Up to approximately 2 years
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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
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Part 2: Clinical Benefit Rate (CBR)
Aikaikkuna: Up to approximately 2 years
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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
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Part 2: Progression-Free Survival (PFS)
Aikaikkuna: Up to approximately 2 years
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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
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Part 2: Number of Participants with Adverse Events (AEs)
Aikaikkuna: Up to approximately 2 years
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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
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Part 2: Recommended Phase 2 Dose (RP2D)
Aikaikkuna: Up to approximately 2 years
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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
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Study Director, BeOne Medicines
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Ihosairaudet
- Rintojen sairaudet
- Iho- ja sidekudostaudit
- Rintojen kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Entsyymin estäjät
- Steroidisynteesin estäjät
- Hormoniantagonistit
- Estrogeeniantagonistit
- Peptidit
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Farmakologiset vaikutukset
- Kemialliset vaikutukset ja käyttötarkoitukset
- Solunsisäiset signalointipeptidit ja proteiinit
- Solusykliproteiinit
- Kasvaimen suppressoriproteiinit
- Neoplasmiproteiinit
- Sykliiniriippuvaiset kinaasi-inhibiittoriproteiinit
- Aromataasi-inhibiittorit
- Sykliiniriippuvainen kinaasi-inhibiittori P16
- Estrogenireseptorin antagonistit
Muut tutkimustunnusnumerot
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 2025 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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-jaon aikakehys
See plan description
IPD-jaon käyttöoikeuskriteerit
See plan description
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- CSR
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