Eine Untersuchungsstudie zu BG-75202 allein und in Kombination mit anderen Therapeutika bei Erwachsenen mit fortgeschrittenen soliden Tumoren
Eine Phase-1a-/1b-Studie zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik, Pharmakodynamik und vorläufigen antitumoralen Aktivität von BG-75202, allein und in Kombination mit anderen Wirkstoffen bei Patienten mit fortgeschrittenen soliden Tumoren
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Study Director
- Telefonnummer: 877-828-5568
- E-Mail: clinicaltrials@beonemed.com
Studienorte
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New South Wales
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Blacktown, New South Wales, Australien, NSW 2148
- Rekrutierung
- Blacktown Cancer and Haematology Centre
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Camperdown, New South Wales, Australien, NSW 2050
- Rekrutierung
- Chris Obrien Lifehouse
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South Australia
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Adelaide, South Australia, Australien, SA 5000
- Rekrutierung
- Cancer Research South Australia
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Victoria
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Heidelberg, Victoria, Australien, VIC 3084
- Rekrutierung
- Austin Health
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Melbourne, Victoria, Australien, VIC 3000
- Rekrutierung
- Peter Maccallum Cancer Centre
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Rekrutierung
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 100021
- Rekrutierung
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400030
- Rekrutierung
- Chongqing University Cancer Hospital
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Fujian
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Xiamen, Fujian, China, 361003
- Rekrutierung
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, China, 510555
- Rekrutierung
- Sun Yat Sen University Cancer Center Huangpu Branch
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Rekrutierung
- Harbin Medical University Cancer Hospital
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Hunan
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Changsha, Hunan, China, 410013
- Rekrutierung
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210036
- Rekrutierung
- Jiangsu Province Hospital Longjiang Branch
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201321
- Rekrutierung
- Fudan University Shanghai Cancer Centerpudong
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Rekrutierung
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Rekrutierung
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Milan, Italien, 20141
- Rekrutierung
- Istituto Europeo Di Oncologia
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Naples, Italien, 80131
- Rekrutierung
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma, Italien, 00168
- Rekrutierung
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano, Italien, 20089
- Rekrutierung
- Istituto Clinico Humanitas
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Auckland, Neuseeland, 1023
- Rekrutierung
- Auckland City Hospital
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Barcelona, Spanien, 08035
- Rekrutierung
- Hospital Universitario Vall Dhebron
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Barcelona, Spanien, 8023
- Rekrutierung
- Next Oncology Barcelona
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Madrid, Spanien, 28041
- Rekrutierung
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28240
- Rekrutierung
- Hospital Clinico San Carlos
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Málaga, Spanien, 29010
- Rekrutierung
- Hospital Universitario Virgen de La Victoria
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294-0004
- Rekrutierung
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06510
- Rekrutierung
- Yale Cancer Center
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110-1010
- Rekrutierung
- Washington University in St Louis
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Texas
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Austin, Texas, Vereinigte Staaten, 78758
- Rekrutierung
- Next Oncology Austin
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Houston, Texas, Vereinigte Staaten, 77030-4009
- Rekrutierung
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle, Washington, Vereinigte Staaten, 98109-4433
- Rekrutierung
- Fred Hutchinson Cancer Research Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Part 1: Number of Participants with Adverse Events (AEs)
Zeitfenster: 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
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Part 1: Recommended Dose for Expansion (RDFE)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Teile 1 und 2: Maximale beobachtete Plasmakonzentration (Cmax) von BG-75202
Zeitfenster: Bis zu ungefähr 4 Monaten
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Bis zu ungefähr 4 Monaten
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Teile 1 und 2: Minimale beobachtete Plasmakonzentration (Ctrough) von BG-75202
Zeitfenster: Bis zu ungefähr 4 Monaten
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Bis zu ungefähr 4 Monaten
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Teile 1 und 2: Fläche unter der Plasmakonzentrations-Zeit-Kurve (AUC) von BG-75202
Zeitfenster: Bis zu etwa 4 Monaten
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Bis zu etwa 4 Monaten
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Teil 1 und 2: Terminale Halbwertszeit (t1/2) von BG-75202
Zeitfenster: Bis zu ungefähr 4 Monaten
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Bis zu ungefähr 4 Monaten
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Part 1: ORR
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
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Part 2: Recommended Phase 2 Dose (RP2D)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Study Director, BeOne Medicines
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Hautkrankheiten
- Brusterkrankungen
- Haut- und Bindegewebserkrankungen
- Neoplasien der Brust
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Enzyminhibitoren
- Steroidsynthese-Inhibitoren
- Hormonantagonisten
- Östrogenantagonisten
- Peptide
- Aminosäuren, Peptide und Proteine
- Proteine
- Pharmakologische Maßnahmen
- Chemische Handlungen und Verwendung
- Intrazelluläre Signalpeptide und Proteine
- Zellzyklusproteine
- Tumorsuppressorproteine
- Neoplasmproteine
- Cyclin-abhängige Kinase-Inhibitorproteine
- Aromatasehemmer
- Cyclin-abhängiger Kinase-Inhibitor P16
- Östrogenrezeptorantagonisten
Andere Studien-ID-Nummern
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 2025 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
See plan description
IPD-Sharing-Zugriffskriterien
See plan description
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
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