BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors

Last updated: April 15, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

BGB-15025

Tislelizumab

Clinical Study ID

NCT04649385
BGB-A317-15025-101
CTR20212721
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Phase 1a (dose escalation): Participants with histologically or cytologicallyconfirmed advanced, metastatic, and unresectable solid tumors who have previouslyreceived standard systemic therapy or for whom treatment is not available, nottolerated or refused, and who have not received prior therapy targeting HPK1

  2. Phase 1b (dose expansion): Participant with histologically or cytologicallyconfirmed advanced, metastatic, and unresectable solid tumors, including non-smallcell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemicanticancer therapies or have no prior systemic treatment for advanced disease

  3. At least 1 measurable lesion as defined per RECIST 1.1.

  4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

  5. Adequate organ function as indicated by the following laboratory values up to firstdose of study treatment: Hemoglobin≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x ULN (< 3 x ULN for participants with Gilbertsyndrome ), AST and ALT≤ 2.5 x ULN

Exclusion

Key Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled and untreated brain metastasis.

  2. Active autoimmune diseases or history of autoimmune diseases that may relapse

  3. Any active malignancy ≤ 2 years before the first dose of study treatment except forthe specific cancer under investigation in this study and any locally recurringcancer that has been treated with curative intent

  4. Any condition that required systemic treatment with either corticosteroids (> 10 mgdaily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 daysbefore the first dose of study treatment

  5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolledlung diseases including but not limited to pulmonary fibrosis, acute lung diseases,etc.

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

Study Design

Total Participants: 157
Treatment Group(s): 2
Primary Treatment: BGB-15025
Phase: 1
Study Start date:
March 04, 2021
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Ashford Cancer Centre Research

    Adelaide, South Australia 5037
    Australia

    Site Not Available

  • Ashford Cancer Centre Research

    Windsor, South Australia 5037
    Australia

    Site Not Available

  • Ashford Cancer Centre Research Northeast

    Windsor Gardens, South Australia 5087
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Linyi Peoples Hospital

    Linyi, Shandong 276000
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • West China Hospital ,Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Tianjin Medical University Cancer institute & Hospital

    Tianjin, Tianjin 300070
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province (East)

    Taizhou, Zhejiang 317004
    China

    Site Not Available

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnamsi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - Oncology

    Seoul, 5505
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • ADHB, Cancer & Blood Research - Auckland Cancer Trials Centre

    Grafton, Auckland 1023
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • Icahn School of Medicine At Mount Sinai

    New York, New York 10029-6504
    United States

    Site Not Available

  • One Gustave L Levy Place

    New York, New York 10029
    United States

    Active - Recruiting

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas 78229-4427
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

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