A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Официальное название

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат BGB-26808
  Planned doses administered orally as a tablet daily.
• Препарат Tislelizumab
  Planned doses administered by intravenous infusion.
• Препарат Chemotherapy
  Administered in accordance with relevant local guidelines and/or prescribing information.

Первичные конечные точки

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: 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]
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808 [Срок оценки: Approximately 1 month]
• Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808 [Срок оценки: Approximately 1 month]
• Phase 1b: Overall Response Rate (ORR) [Срок оценки: Approximately 6 months]

Вторичные конечные точки (12)

• Phase 1a: ORR [Срок оценки: Approximately 6 months]
• Phase 1a and 1b: Duration of Response (DOR) [Срок оценки: Approximately 9 months]
• Phase 1a and 1b: Disease Control Rate (DCR) [Срок оценки: Approximately 6 months]
• Phase 1a and 1b: Clinical Benefit Rate (CBR) [Срок оценки: Approximately 6 months]
• Phase 1b: Progression Free Survival (PFS) [Срок оценки: Approximately 9 months]
• Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808 [Срок оценки: Approximately 1 month]
• Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808 [Срок оценки: Approximately 6 months]
• Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808 [Срок оценки: Approximately 1 month]
• Phase 1a: Half-life (t1/2) for BGB-26808 [Срок оценки: Approximately 1 month]
• Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808 [Срок оценки: Approximately 2 months]
• Phase 1a: Apparent clearance (CL/F) for BGB-26808 [Срок оценки: Approximately 1 month]
• Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808 [Срок оценки: Approximately 1 month]

Критерии участия

Критерии включения

• 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 ≥ 180 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch — Хэфэй
• Harbin Medical University Cancer Hospital — Харбин
• Hubei Cancer Hospital — Ухань
• Tongji Hospital,Tongji Medical College of Hustsino French New City Branch — Ухань
• The First Hospital of China Medical University Hunnan Branch — Шэньян
• Jining No1 Peoples Hospital West Branch — Jining
• Yantai Yuhuangding Hospital — Yantai
• Shanghai East Hospital Branch Hospital — Шанхай
• … и ещё 4 центра

США · 9 центров

• City of Hope National Medical Center — Duarte
• University of Southern California Norris Comprehensive — Los Angeles
• Yale University Yale Cancer Center — New Haven
• Sylvester Cancer Center, University of Miami — Miami
• University of Michigan Health System — Ann Arbor
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack
• Icahn School of Medicine At Mount Sinai — New York
• Providence Portland Medical Center — Portland
• … и ещё 1 центр

Австралия · 4 центра

• Southside Cancer Care — Miranda
• Macquarie University — North Ryde
• Icon Cancer Centre Kurralta Park — Kurralta Park
• Linear Clinical Research — Nedlands

Новая Зеландия · 3 центра

• Auckland City Hospital — Auckland
• Harbour Cancer and Wellness — Auckland
• Health New Zealand Te Whatu Ora Lakes Rotorua Hospital — Rotorua

Идентификаторы

NCT: NCT05981703 · BGB-A317-26808-101 · CTR20240210

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20240210 (платформа chinadrugtrials.org.cn)

Открыть это исследование на ClinicalTrials.gov ↗