Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

Last updated: May 7, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

Drug: BG-T187

Clinical Study ID

NCT06598800
BG-T187-101
2024-514944-10-00
  • Ages > 18
  • All Genders

Study Summary

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to provide a signed and dated written informed consent prior to anystudy-specific procedures, sampling, or data collection.

  2. Patients must be ≥ 18 years of age or the legal age of consent in the jurisdictionin which the study is taking place.

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

  4. Participants with selected histologically or cytologically confirmed advanced,metastatic, and unresectable solid tumors who have been previously treated.

  5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a PartA; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.

  6. Adequate organ function.

Exclusion

Exclusion Criteria:

  1. Prior severe allergic reactions or hypersensitivity to the active ingredient andexcipients of BG-T187 or other monoclonal antibodies.

  2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreatedbrain metastasis.

  3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

  4. History of ILD or noninfectious pneumonitis requiring steroids or other immunesuppressive agents ≤ 2 years before the first dose of the study drug, or withcurrent ILD/noninfectious pneumonitis, or where suspected ILD/noninfectiouspneumonitis cannot be ruled out by imaging during screening.

  5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequentdrainage (recurrence ≤14 days after intervention).

  6. Active hepatitis C.

  7. Infection (including tuberculosis infection, or other) requiring systemic (oral orintravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before thefirst dose of study drug(s).

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

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Drug: BG-T187
Phase: 1
Study Start date:
October 18, 2024
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Macquarie University

    North Ryde, New South Wales 2109
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern East, Victoria 3144
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • The Sixth Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong 510655
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding, Hebei 071000
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601-1915
    United States

    Site Not Available

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Next Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Washington University, St Louis, Division of Oncology

    Madison, Wisconsin 53708-8056
    United States

    Site Not Available

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