An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
En fase 1a/1b-studie, der evaluerer sikkerheden, tolerabiliteten, farmakokinetikken, farmakodynamikken og den foreløbige antikanceraktivitet af BG-75202, både alene og i kombination med andre midler, hos patienter med fremskreden solid tumor
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will enroll participants with advanced or metastatic solid tumors, including breast cancer. Breast cancer is one of the most common cancers in women.
BG-75202 is an experimental drug that blocks proteins called KAT6A and 6B. These proteins are believed to help tumor growth in a number of cancers including certain types of breast cancer and other solid tumors. By blocking KAT6A and 6B, BG-75202 may be able to slow down or stop the growth of tumor cells.
This study consists of 2 parts, one called dose escalation and safety expansion and the other called dose optimization and dose expansion.
During the dose escalation and safety expansion part, the study doctors will test different doses of the study drug. This part of the study will evaluate BG-75202 alone (monotherapy) and combined with another drug (combination therapy).
During the dose optimization and dose expansion part, the study doctors will test the study drug in a larger number of people using the dose(s) identified from dose escalation and safety expansion. In this part of the study, BG-75202 will be taken with 1 or 2 other drugs.
The study will enroll participants with advanced or metastatic solid tumors at multiple centers worldwide.
The overall time to participate in this study may be up to approximately five years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Study Director
- Telefonnummer: 877-828-5568
- E-mail: clinicaltrials@beonemed.com
Studiesteder
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New South Wales
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Blacktown, New South Wales, Australien, NSW 2148
- Rekruttering
- Blacktown Cancer and Haematology Centre
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Camperdown, New South Wales, Australien, NSW 2050
- Rekruttering
- Chris Obrien Lifehouse
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South Australia
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Adelaide, South Australia, Australien, SA 5000
- Rekruttering
- Cancer Research South Australia
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Victoria
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Heidelberg, Victoria, Australien, VIC 3084
- Rekruttering
- Austin Health
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Melbourne, Victoria, Australien, VIC 3000
- Rekruttering
- Peter Maccallum Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294-0004
- Rekruttering
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Yale Cancer Center
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Missouri
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St Louis, Missouri, Forenede Stater, 63110-1010
- Rekruttering
- Washington University in St Louis
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Texas
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Austin, Texas, Forenede Stater, 78758
- Rekruttering
- Next Oncology Austin
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Houston, Texas, Forenede Stater, 77030-4009
- Rekruttering
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle, Washington, Forenede Stater, 98109-4433
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- Fred Hutchinson Cancer Research Center
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Milan, Italien, 20141
- Rekruttering
- Istituto Europeo Di Oncologia
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Naples, Italien, 80131
- Rekruttering
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano, Italien, 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
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- Auckland City Hospital
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Barcelona, Spanien, 08035
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- Hospital Universitario Vall Dhebron
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Barcelona, Spanien, 8023
- Rekruttering
- Next Oncology Barcelona
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28240
- Rekruttering
- Hospital Clinico San Carlos
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Málaga, Spanien, 29010
- Rekruttering
- Hospital Universitario Virgen de La Victoria
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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, Part 2A, 2B, and SE Parts 1A and 1B (except Food Effect): 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 1 line of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload) in the advanced/metastatic setting.
- Food Effect only in SE Parts 1A or 1B: Patients with histologically or cytologically confirmed advanced, metastatic breast cancer who have exhausted, are intolerant of all available standard-of-care therapies, and/or without available standard-of-care therapies.
- Parts 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 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 |
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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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. |
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Eksperimentel: Part 2B: Safety Lead-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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Part 1 and Part 2B (Safety Lead-in): 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 and Part 2B (Safety Lead-in): 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 A and Part 2C: 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 |
Foranstaltningsbeskrivelse |
Tidsramme |
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Del 1 og 2: Maksimal observeret plasmakoncentration (Cmax) af BG-75202
Tidsramme: Op til cirka 4 måneder
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Op til cirka 4 måneder
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Del 1 og 2: Minimum observeret plasmakoncentration (Ctrough) af BG-75202
Tidsramme: I op til cirka 4 måneder
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I op til cirka 4 måneder
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Del 1 og 2: Areal under plasmakoncentrations-tidskurven (AUC) for BG-75202
Tidsramme: Op til cirka 4 måneder
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Op til cirka 4 måneder
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Del 1 og 2: Halveringstid (t1/2) for BG-75202
Tidsramme: Op til cirka 4 måneder
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Op til cirka 4 måneder
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Part 1 and Part 2B (Safety Lead-in): 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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Duration of Response (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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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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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: Time to Response (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 2A and Part 2C: 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 2A and Part 2C: 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 2A and Part 2C: Recommended Phase 2 Dose (RP2D) or Recommended Phase 3 Dose (RP3D)
Tidsramme: Up to approximately 2 years
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The RP2D or RP3D 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Study Director, BeOne Medicines
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Hudsygdomme
- Brystsygdomme
- Hud- og bindevævssygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Hormoner, hormonsubstitutter og hormonantagonister
- Enzymhæmmere
- Steroidsyntesehæmmere
- Hormonantagonister
- Østrogenantagonister
- Peptider
- Aminosyrer, peptider og proteiner
- Proteiner
- Farmakologiske handlinger
- Kemiske handlinger og anvendelser
- Intracellulære signalpeptider og proteiner
- Cellecyklusproteiner
- Tumorundertrykkende proteiner
- Neoplasma -proteiner
- Cyclin-afhængige kinaseinhibitorproteiner
- Aromatasehæmmere
- Cyclin-afhængig kinaseinhibitor P16
- Østrogenreceptorantagonister
Andre undersøgelses-id-numre
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
IPD-delingsadgangskriterier
See plan description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
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