En undersøkende studie av BG-75202 alene og i kombinasjon med andre terapeutiske midler hos voksne med avanserte solide tumorer
En fase 1a/1b-studie som evaluerer sikkerhet, tolerabilitet, farmakokinetikk, farmakodynamikk og foreløpig antikreftaktivitet av BG-75202, både alene og i kombinasjon med andre midler hos pasienter med avanserte solide svulster
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Study Director
- Telefonnummer: 877-828-5568
- E-post: clinicaltrials@beonemed.com
Studiesteder
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Rekruttering
- Blacktown Cancer and Haematology Centre
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Camperdown, New South Wales, Australia, NSW 2050
- Rekruttering
- Chris Obrien Lifehouse
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South Australia
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Adelaide, South Australia, Australia, SA 5000
- Rekruttering
- Cancer Research South Australia
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Victoria
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Heidelberg, Victoria, Australia, VIC 3084
- Rekruttering
- Austin Health
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Melbourne, Victoria, Australia, VIC 3000
- Rekruttering
- Peter Maccallum Cancer Centre
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Alabama
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Birmingham, Alabama, Forente stater, 35294-0004
- Rekruttering
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Yale Cancer Center
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Missouri
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St Louis, Missouri, Forente stater, 63110-1010
- Rekruttering
- Washington University in St Louis
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Texas
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Austin, Texas, Forente stater, 78758
- Rekruttering
- Next Oncology Austin
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Houston, Texas, Forente stater, 77030-4009
- Rekruttering
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle, Washington, Forente stater, 98109-4433
- Rekruttering
- Fred Hutchinson Cancer Research Center
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Milan, Italia, 20141
- Rekruttering
- Istituto Europeo Di Oncologia
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Naples, Italia, 80131
- Rekruttering
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano, Italia, 20089
- Rekruttering
- Istituto Clinico Humanitas
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kina, 100021
- Rekruttering
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400030
- Rekruttering
- Chongqing University Cancer Hospital
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Fujian
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Xiamen, Fujian, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Kina, 510555
- Rekruttering
- Sun Yat Sen University Cancer Center Huangpu Branch
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekruttering
- Harbin Medical University Cancer Hospital
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Hunan
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Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, Kina, 210036
- Rekruttering
- Jiangsu Province Hospital Longjiang Branch
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 201321
- Rekruttering
- Fudan University Shanghai Cancer Centerpudong
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Rekruttering
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Auckland, New Zealand, 1023
- Rekruttering
- Auckland City Hospital
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Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitario Vall Dhebron
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Barcelona, Spania, 8023
- Rekruttering
- Next Oncology Barcelona
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Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Madrid, Spania, 28240
- Rekruttering
- Hospital Clinico San Carlos
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Málaga, Spania, 29010
- Rekruttering
- Hospital Universitario Virgen de La Victoria
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Part 1: 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 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Del 1 og 2: Maksimal observert plasmakonsentrasjon (Cmax) av BG-75202
Tidsramme: Opptil omtrent 4 måneder
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Opptil omtrent 4 måneder
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Del 1 og 2: Minimum observerte plasmakonsentrasjon (Ctrough) av BG-75202
Tidsramme: Opptil omtrent 4 måneder
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Opptil omtrent 4 måneder
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Del 1 og 2: Areal under plasmakonsentrasjon-tid-kurven (AUC) for BG-75202
Tidsramme: Opptil omtrent 4 måneder
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Opptil omtrent 4 måneder
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Del 1 og 2: Terminal halveringstid (t1/2) for BG-75202
Tidsramme: Opptil omtrent 4 måneder
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Opptil omtrent 4 måneder
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Part 1: ORR
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Study Director, BeOne Medicines
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Hudsykdommer
- Bryst sykdommer
- Hud- og bindevevssykdommer
- Brystneoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Hormoner, hormonsubstitutter og hormonantagonister
- Enzymhemmere
- Steroidesyntesehemmere
- Hormonantagonister
- Østrogenantagonister
- Peptider
- Aminosyrer, peptider og proteiner
- Proteiner
- Farmakologiske handlinger
- Kjemiske handlinger og bruk
- Intracellulære signalpeptider og proteiner
- Cellesyklusproteiner
- Tumorundertrykkende proteiner
- Neoplasma proteiner
- Syklinavhengige kinaseinhibitorproteiner
- Aromatasehemmere
- Cyclin-avhengig kinaseinhibitor P16
- Østrogenreseptorantagonister
Andre studie-ID-numre
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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
Tilgangskriterier for IPD-deling
See plan description
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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