Uno studio che indaga sul BGB-26808 da solo o in combinazione con tislelizumab nei partecipanti con tumori solidi avanzati
Uno studio di fase 1 che indaga la sicurezza, la tollerabilità, la farmacocinetica e l'attività antitumorale preliminare dell'inibitore HPK1 BGB-26808 da solo o in combinazione con l'anticorpo monoclonale anti-PD-1 Tislelizumab in pazienti con tumori solidi avanzati
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Study Director
- Numero di telefono: 1.877.828.5568
- Email: clinicaltrials@beonemed.com
Luoghi di studio
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New South Wales
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Miranda, New South Wales, Australia, NSW 2228
- Completato
- Southside Cancer Care
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North Ryde, New South Wales, Australia, NSW 2109
- Attivo, non reclutante
- Macquarie University
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South Australia
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Kurralta Park, South Australia, Australia, SA 5037
- Attivo, non reclutante
- Icon Cancer Centre Kurralta Park
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Western Australia
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Nedlands, Western Australia, Australia, WA 6009
- Completato
- Linear Clinical Research
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Anhui
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Hefei, Anhui, Cina, 230022
- Reclutamento
- The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
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Heilongjiang
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Harbin, Heilongjiang, Cina, 150000
- Reclutamento
- Harbin Medical University Cancer Hospital
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Hubei
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Wuhan, Hubei, Cina, 430079
- Reclutamento
- Hubei Cancer Hospital
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Wuhan, Hubei, Cina, 430101
- Reclutamento
- Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
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Liaoning
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Shenyang, Liaoning, Cina, 110167
- Reclutamento
- The First Hospital of China Medical University Hunnan Branch
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Shandong
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Jining, Shandong, Cina, 272000
- Reclutamento
- Jining No1 Peoples Hospital West Branch
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Yantai, Shandong, Cina, 264000
- Reclutamento
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200123
- Reclutamento
- Shanghai East Hospital Branch Hospital
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Shanghai, Shanghai Municipality, Cina, 200433
- Completato
- Shanghai Pulmonary Hospital
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Sichuan
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Chengdu, Sichuan, Cina, 610071
- Reclutamento
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310006
- Reclutamento
- Hangzhou First Peoples Hospital
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Taizhou, Zhejiang, Cina, 317004
- Completato
- Taizhou Hospital of Zhejiang Province (East)
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Auckland, Nuova Zelanda, 1023
- Reclutamento
- Auckland City Hospital
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Auckland, Nuova Zelanda, 1023
- Reclutamento
- Harbour Cancer and Wellness
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Rotorua, Nuova Zelanda, 3010
- Reclutamento
- Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
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California
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Duarte, California, Stati Uniti, 91010-3012
- Reclutamento
- City of Hope National Medical Center
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Los Angeles, California, Stati Uniti, 90033
- Reclutamento
- University of Southern California Norris Comprehensive
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520-8028
- Reclutamento
- Yale University Yale Cancer Center
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Florida
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Miami, Florida, Stati Uniti, 33136
- Reclutamento
- Sylvester Cancer Center, University of Miami
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-5316
- Reclutamento
- University of Michigan Health System
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Reclutamento
- John Theurer Cancer Center Hackensack University Medical Center
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New York
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New York, New York, Stati Uniti, 10029-6504
- Reclutamento
- Icahn School of Medicine At Mount Sinai
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Oregon
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Portland, Oregon, Stati Uniti, 97213-2933
- Completato
- Providence Portland Medical Center
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Texas
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Houston, Texas, Stati Uniti, 77030-4009
- Reclutamento
- The University of Texas Md Anderson Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
Administered in accordance with relevant local guidelines and/or prescribing information. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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
|
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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Phase 1a and 1b: Plasma concentrations of BGB-26808
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Approximately 1 month
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Approximately 1 month
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Phase 1a: ORR
Lasso di tempo: Approximately 6 months
|
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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Approximately 1 month
|
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
Lasso di tempo: 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
|
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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Study Director, BeOne Medicines
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BGB-A317-26808-101
- CTR20240210 (Altro identificatore: ChinaDrugTrials)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
See plan description
Criteri di accesso alla condivisione IPD
See plan description
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .