Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

May 7, 2026 updated by: BeOne Medicines

An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene or BeOne investigational drugs in participants with advanced malignancies who participated in a prior BeiGene- or BeOne-sponsored clinical study (parent study).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

For the purposes of this study, "study treatment" will refer to all investigational agents. A parent study is defined as the original BeiGene- or BeOne-sponsored clinical trial in which the participant was initially enrolled and received BeiGene or BeOne investigational drugs (with or without other treatments).

Note: 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.

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, NSW 2031
        • Prince of Wales Hospital
      • St Leonards, New South Wales, Australia, NSW 2065
        • Northern Cancer Institute
      • Waratah, New South Wales, Australia, NSW 2298
        • Calvary Mater Newcastle
    • Queensland
      • South Brisbane, Queensland, Australia, QLD 4101
        • Icon Cancer Centre South Brisbane
    • South Australia
      • Woodville South, South Australia, Australia, SA 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
      • Melbourne, Victoria, Australia, VIC 3000
        • Peter MacCallum Cancer Centre
  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, China, 100071
        • The Affiliated Hospital of Military Medical Sciences
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
      • Guangzhou, Guangdong, China, 510245
        • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
      • Guangzhou, Guangdong, China, 510030
        • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
      • Zhuhai, Guangdong, China, 519000
        • The Fifth Affiliated Hospital Sun Yat Sen University
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The Peoples Hospital of Guangxi Zhuang Autonomous Region
    • Guizhou
      • Zuiyi, Guizhou, China, 550002
        • The Second Affiliated Hospital of Zunyi Medical University
    • Hainan
      • Haikou, Hainan, China, 570312
        • Hainan Cancer Hospital
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University Wuhan
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • The First Peoples Hospital of Changzhou
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University Branch Donghu
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130021
        • Jilin Cancer Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • First Affiliated Hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital and Institute
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xiân Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Weifang, Shandong, China, 261000
        • Weifang Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, Shanghai Municipality, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
      • Shanghai, Shanghai Municipality, China, 200092
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610101
        • West China Second University Hospital, Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of Hematology and Hospital of Blood Disease
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Affiliated Cancer Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • The First Provincial Wenzhou Hospital of Zhejiang
  • France
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Lyon, France, 69008
        • Hopital Privé Jean Mermoz
      • Montpellier, France, 34090
        • Icm Val Daurelle
      • Nantes, France, 44000
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Nice, France, 06200
        • Hopital Larchet 2 Chu Nice
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sorsola Malpighi, Aou Di Bologna
      • Pisa, Italy, 56126
        • Aou Pisana, Stabilimento Di Santa Chiara
      • Terni, Italy, 05100
        • Azienda Ospedaliera S Maria Di Terni
  • Japan
    • Akita
      • Akitashi, Akita, Japan, 010-8543
        • Akita University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • NHO Kyushu Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Osaka
      • Izumishi, Osaka, Japan, 594-0073
        • Izumi City General Hospital
      • Suitashi, Osaka, Japan, 565-0871
        • The University of Osaka Hospital
    • Tokyo
      • ChuoKu, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuching, Malaysia, 93586
        • Sarawak General Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Poland
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
  • South Korea
      • Suwon, South Korea, 16499
        • Ajou University Hospital
    • Gyeonggi-do
      • BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408
        • National Cancer Center (Korea)
      • PaldalGu SuwonSi, Gyeonggi-do, South Korea, 16247
        • The Catholic University of Korea, St Vincents Hospital
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Incheon Gwang'yeogsi
      • NamdongGu, Incheon Gwang'yeogsi, South Korea, 21565
        • Gachon University Gil Medical Center
    • Jeollanam-do
      • HwasunGun, Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
    • Seoul Teugbyeolsi
      • DongjakGu, Seoul Teugbyeolsi, South Korea, 07061
        • Smg Snu Boramae Medical Center
      • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center
      • GuroGu, Seoul Teugbyeolsi, South Korea, 08308
        • Korea University Guro Hospital
      • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St Marys Hospital
      • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital
      • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center
  • Taiwan
      • Chiayi City, Taiwan, 61363
        • Chiayi Chang Gung Memorial Hospital
      • Guishan Dist, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
      • Niaosong Dist, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • North Dist, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Yongkang Dist, Taiwan, 710
        • Chi Mei Medical Center
  • Thailand
      • Pathum Wan, Thailand, 10330
        • King Chulalongkorn Memorial Hospital (Chulalongkorn University)
  • Turkey (Türkiye)
      • Kuruköprü, Turkey (Türkiye), 01060
        • Acibadem Adana Hospital
      • Tekirdağ, Turkey (Türkiye), 59100
        • Namik Kemal University
      • stanbulBakrkoy, Turkey (Türkiye), 34147
        • Bakirkoy Sadi Konuk Eah
  • United States
    • Florida
      • Miami, Florida, United States, 33140-2840
        • Mount Sinai Comprehensive Cancer Center
    • New York
      • New York, New York, United States, 10065-6800
        • Memorial Sloan Kettering Cancer Center Mskcc
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, Pllc Nashville
    • Texas
      • Dallas, Texas, United States, 75246-2079
        • Baylor Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Currently participating in a BeiGene- or BeOne-sponsored eligible parent study
  2. Fulfills treatment criteria specified in the parent study protocol
  3. In the opinion of the investigator, the participant will continue to benefit from and tolerate any of the parent study treatments.

  4. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study:

    1. "Treatment interruption" is an unplanned pause in study treatment (eg, due to adverse event). Restarting study treatment beyond the interruption period allowed by the parent study will be determined by the investigator and the sponsor.

Key Exclusion Criteria:

  1. Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
  2. Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study
  3. Have a medical condition or organ system dysfunction that in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of investigational drugs, or put the study outcomes at undue risk
  4. Underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the LTE study
  5. Pregnant or lactating women

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A - Tislelizumab Monotherapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Experimental: B - Pamiparib Monotherapy
Drug: Pamiparib
Administered orally.
Other Names:
  • BGB-290
Experimental: C - Sitravatinib Monotherapy
Drug: Sitravatinib
Administered orally.
Experimental: D - BGB-15025 Monotherapy
Drug: BGB-15025
Administered orally.
Experimental: E - Zanidatamab Monotherapy
Drug: Zanidatamab
Administered intravenously.
Other Names:
  • ZW25
Experimental: F - Pamiparib and Temozolomide Combination Therapy
Drug: Pamiparib
Administered orally.
Other Names:
  • BGB-290
Drug: Temozolomide
Administered orally.
Experimental: G - Tislelizumab and Pamiparib Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Pamiparib
Administered orally.
Other Names:
  • BGB-290
Experimental: H - Tislelizumab and Sitravatinib Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Sitravatinib
Administered orally.
Experimental: I - Tislelizumab and Ociperlimab Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Ociperlimab
Administered intravenously.
Other Names:
  • BGB-A1217
Experimental: J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: BAT1706
Administered intravenously.
Experimental: K - Tislelizumab and Fruquintinib Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Fruquintinib
Administered orally.
Experimental: L - Tislelizumab and BGB-A445 Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: BGB-A445
Administered intravenously.
Other Names:
  • Gimistotug
Experimental: M - Tislelizumab and Surzebiclimab Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Administered intravenously.
Other Names:
  • BGB-A425
Experimental: N - Tislelizumab and BGB-15025 Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: BGB-15025
Administered orally.
Experimental: O - Tislelizumab and Lenvatinib Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Lenvatinib
Administered orally.
Experimental: P - Tislelizumab and Zanidatamab Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Zanidatamab
Administered intravenously.
Other Names:
  • ZW25
Experimental: Q - Tislelizumab and LBL-007 Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: LBL-007
Administered intravenously.
Other Names:
  • Alcestobart
Experimental: R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy
Drug: Tislelizumab
Administered intravenously.
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Administered intravenously.
Other Names:
  • BGB-A425
Drug: LBL-007
Administered intravenously.
Other Names:
  • Alcestobart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher
Time Frame: up to 7 years
Safety as assessed by the number of participants with immune-mediated adverse events (imAEs), ≥ Grade 3 adverse events, and serious adverse events.
up to 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 7 years
Overall survival defined as the time from start of treatment in the parent study (or randomization date for a randomized parent study) until the date of death from any cause.
up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeOne Medicines

Investigators

  • Study Director: Study Director, BeOne Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-A317-290-LTE1
  • 2019-002554-23 (EudraCT Number)
  • 2023-508883-31-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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