Studie zkoumající BGB-26808 samostatně nebo v kombinaci s tislelizumabem u účastníků s pokročilými solidními nádory
Studie fáze 1 zkoumající bezpečnost, snášenlivost, farmakokinetiku a předběžnou protinádorovou aktivitu inhibitoru HPK1 BGB-26808 samotného nebo v kombinaci s monoklonální protilátkou anti-PD-1 tislelizumabem u pacientů s pokročilými solidními nádory
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Study Director
- Telefonní číslo: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Studijní místa
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New South Wales
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Miranda, New South Wales, Austrálie, NSW 2228
- Dokončeno
- Southside Cancer Care
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North Ryde, New South Wales, Austrálie, NSW 2109
- Aktivní, ne nábor
- Macquarie University
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South Australia
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Kurralta Park, South Australia, Austrálie, SA 5037
- Aktivní, ne nábor
- Icon Cancer Centre Kurralta Park
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Western Australia
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Nedlands, Western Australia, Austrálie, WA 6009
- Dokončeno
- Linear Clinical Research
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Auckland, Nový Zéland, 1023
- Nábor
- Auckland City Hospital
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Auckland, Nový Zéland, 1023
- Nábor
- Harbour Cancer and Wellness
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Rotorua, Nový Zéland, 3010
- Nábor
- Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
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California
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Duarte, California, Spojené státy, 91010-3012
- Nábor
- City of Hope National Medical Center
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Los Angeles, California, Spojené státy, 90033
- Nábor
- University of Southern California Norris Comprehensive
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520-8028
- Nábor
- Yale University Yale Cancer Center
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Florida
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Miami, Florida, Spojené státy, 33136
- Nábor
- Sylvester Cancer Center, University of Miami
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109-5316
- Nábor
- University of Michigan Health System
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Nábor
- John Theurer Cancer Center Hackensack University Medical Center
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New York
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New York, New York, Spojené státy, 10029-6504
- Nábor
- Icahn School of Medicine At Mount Sinai
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Oregon
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Portland, Oregon, Spojené státy, 97213-2933
- Dokončeno
- Providence Portland Medical Center
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Texas
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Houston, Texas, Spojené státy, 77030-4009
- Nábor
- The University of Texas Md Anderson Cancer Center
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Anhui
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Hefei, Anhui, Čína, 230022
- Nábor
- The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
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Heilongjiang
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Harbin, Heilongjiang, Čína, 150000
- Nábor
- Harbin Medical University Cancer Hospital
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Hubei
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Wuhan, Hubei, Čína, 430079
- Nábor
- Hubei Cancer Hospital
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Wuhan, Hubei, Čína, 430101
- Nábor
- Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
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Liaoning
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Shenyang, Liaoning, Čína, 110167
- Nábor
- The First Hospital of China Medical University Hunnan Branch
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Shandong
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Jining, Shandong, Čína, 272000
- Nábor
- Jining No1 Peoples Hospital West Branch
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Yantai, Shandong, Čína, 264000
- Nábor
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200123
- Nábor
- Shanghai East Hospital Branch Hospital
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Shanghai, Shanghai Municipality, Čína, 200433
- Dokončeno
- Shanghai Pulmonary Hospital
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Sichuan
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Chengdu, Sichuan, Čína, 610071
- Nábor
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Čína, 310006
- Nábor
- Hangzhou First Peoples Hospital
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Taizhou, Zhejiang, Čína, 317004
- Dokončeno
- Taizhou Hospital of Zhejiang Province (East)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
- Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
- Adequate organ function.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for up to ≥ 270 days after the last dose of chemotherapy.
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.
Exclusion Criteria:
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment(s).
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
- Uncontrolled diabetes.
- Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Phase 1a: Dose Escalation
Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab. |
Planned doses administered orally as a tablet daily. Planned doses administered by intravenous infusion.
Ostatní jména:
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Experimentální: Phase 1b: Dose Expansion
Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated. |
Planned doses administered orally as a tablet daily. Planned doses administered by intravenous infusion.
Ostatní jména:
Administered in accordance with relevant local guidelines and/or prescribing information. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: From the first dose of study drug(s) to 90 days after the 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 AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria. |
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
Časové okno: Approximately 1 month
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MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. |
Approximately 1 month
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Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
Časové okno: Approximately 1 month
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RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD. |
Approximately 1 month
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Phase 1b: Overall Response Rate (ORR)
Časové okno: Approximately 6 months
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ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
Approximately 6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Phase 1a and 1b: Plasma concentrations of BGB-26808
Časové okno: Approximately 6 months
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Approximately 6 months
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Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
Časové okno: Approximately 1 month
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Approximately 1 month
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Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
Časové okno: Approximately 1 month
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Approximately 1 month
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Phase 1a: ORR
Časové okno: Approximately 6 months
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ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1. |
Approximately 6 months
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Phase 1a and 1b: Duration of Response (DOR)
Časové okno: Approximately 9 months
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DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. |
Approximately 9 months
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Phase 1a and 1b: Disease Control Rate (DCR)
Časové okno: Approximately 6 months
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DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator. |
Approximately 6 months
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Phase 1a and 1b: Clinical Benefit Rate (CBR)
Časové okno: Approximately 6 months
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CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator. |
Approximately 6 months
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Phase 1b: Progression Free Survival (PFS)
Časové okno: Approximately 9 months
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PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. |
Approximately 9 months
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Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
Časové okno: Approximately 1 month
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Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters. |
Approximately 1 month
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Phase 1b: Number of Participants with AEs and SAEs
Časové okno: From the first dose of study drug(s) to 90 days after the 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 AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria. |
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Study Director, BeOne Medicines
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BGB-A317-26808-101
- CTR20240210 (Jiný identifikátor: ChinaDrugTrials)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
See plan description
Kritéria přístupu pro sdílení IPD
See plan description
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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