이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

진행성 고형 종양이 있는 참가자에서 BGB-26808 단독 또는 Tislelizumab과의 병용을 조사하는 연구

2026년 9월 24일 업데이트: BeOne Medicines

진행성 고형 종양 환자에서 HPK1 억제제 BGB-26808 단독 또는 항-PD-1 단일클론 항체 Tislelizumab과 병용의 안전성, 내약성, 약동학 및 예비 항종양 활성을 조사하는 1상 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

337

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 뉴질랜드
      • Auckland, 뉴질랜드, 1023
        • 모병
        • Auckland City Hospital
      • Auckland, 뉴질랜드, 1023
        • 모병
        • Harbour Cancer and Wellness
      • Rotorua, 뉴질랜드, 3010
        • 모병
        • Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
  • 미국
    • California
      • Duarte, California, 미국, 91010-3012
        • 모병
        • City of Hope National Medical Center
      • Los Angeles, California, 미국, 90033
        • 모병
        • University of Southern California Norris Comprehensive
    • Connecticut
      • New Haven, Connecticut, 미국, 06520-8028
        • 모병
        • Yale University Yale Cancer Center
    • Florida
      • Miami, Florida, 미국, 33136
        • 모병
        • Sylvester Cancer Center, University of Miami
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109-5316
        • 모병
        • University of Michigan Health System
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • 모병
        • John Theurer Cancer Center Hackensack University Medical Center
    • New York
      • New York, New York, 미국, 10029-6504
        • 모병
        • Icahn School of Medicine At Mount Sinai
    • Oregon
      • Portland, Oregon, 미국, 97213-2933
        • 완전한
        • Providence Portland Medical Center
    • Texas
      • Houston, Texas, 미국, 77030-4009
        • 모병
        • The University of Texas Md Anderson Cancer Center
  • 중국
    • Anhui
      • Hefei, Anhui, 중국, 230022
        • 모병
        • The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
    • Heilongjiang
      • Harbin, Heilongjiang, 중국, 150000
        • 모병
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, 중국, 430079
        • 모병
        • Hubei Cancer Hospital
      • Wuhan, Hubei, 중국, 430101
        • 모병
        • Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
    • Liaoning
      • Shenyang, Liaoning, 중국, 110167
        • 모병
        • The First Hospital of China Medical University Hunnan Branch
    • Shandong
      • Jining, Shandong, 중국, 272000
        • 모병
        • Jining No1 Peoples Hospital West Branch
      • Yantai, Shandong, 중국, 264000
        • 모병
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200123
        • 모병
        • Shanghai East Hospital Branch Hospital
      • Shanghai, Shanghai Municipality, 중국, 200433
        • 완전한
        • Shanghai Pulmonary Hospital
    • Sichuan
      • Chengdu, Sichuan, 중국, 610071
        • 모병
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310006
        • 모병
        • Hangzhou First Peoples Hospital
      • Taizhou, Zhejiang, 중국, 317004
        • 완전한
        • Taizhou Hospital of Zhejiang Province (East)
  • 호주
    • New South Wales
      • Miranda, New South Wales, 호주, NSW 2228
        • 완전한
        • Southside Cancer Care
      • North Ryde, New South Wales, 호주, NSW 2109
        • 모집하지 않고 적극적으로
        • Macquarie University
    • South Australia
      • Kurralta Park, South Australia, 호주, SA 5037
        • 모집하지 않고 적극적으로
        • Icon Cancer Centre Kurralta Park
    • Western Australia
      • Nedlands, Western Australia, 호주, WA 6009
        • 완전한
        • Linear Clinical Research

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. 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).
  4. 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.
  5. ≥ 1 measurable lesion per RECIST v1.1.
  6. Able to provide an archived tumor tissue sample.
  7. Adequate organ function.
  8. 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.
  9. 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:

  1. 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.
  2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
  3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
  4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse
  6. 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).
  7. 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).
  8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
  9. Uncontrolled diabetes.
  10. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Phase 1a: Dose Escalation

Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
의약품: BGB-26808

Planned doses administered orally as a tablet daily.

의약품: Tislelizumab

Planned doses administered by intravenous infusion.

다른 이름들:
  • BGB-A317
실험적: Phase 1b: Dose Expansion

Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.
의약품: BGB-26808

Planned doses administered orally as a tablet daily.

의약품: Tislelizumab

Planned doses administered by intravenous infusion.

다른 이름들:
  • BGB-A317
의약품: Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: 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
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
기간: Approximately 1 month

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
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
기간: Approximately 1 month

RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
Approximately 1 month
Phase 1b: Overall Response Rate (ORR)
기간: 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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Approximately 6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Phase 1a and 1b: Plasma concentrations of BGB-26808
기간: Approximately 6 months
Approximately 6 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
기간: Approximately 1 month
Approximately 1 month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
기간: Approximately 1 month
Approximately 1 month
Phase 1a: ORR
기간: 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
Phase 1a and 1b: Duration of Response (DOR)
기간: Approximately 9 months

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
Phase 1a and 1b: Disease Control Rate (DCR)
기간: Approximately 6 months

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
Phase 1a and 1b: Clinical Benefit Rate (CBR)
기간: Approximately 6 months

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
Phase 1b: Progression Free Survival (PFS)
기간: Approximately 9 months

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
Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
기간: 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
Phase 1b: Number of Participants with AEs and SAEs
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

BeOne Medicines

수사관

  • 연구 책임자: Study Director, BeOne Medicines

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 9월 21일

기본 완료 (추정된)

2029년 2월 28일

연구 완료 (추정된)

2029년 2월 28일

연구 등록 날짜

최초 제출

2023년 7월 31일

QC 기준을 충족하는 최초 제출

2023년 7월 31일

처음 게시됨 (실제)

2023년 8월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BGB-A317-26808-101
  • CTR20240210 (기타 식별자: ChinaDrugTrials)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

See plan description

IPD 공유 액세스 기준

See plan description

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다