Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
NCT ID: NCT06598800
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
87 participants
INTERVENTIONAL
2024-10-18
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration
Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
Drug: BG-T187
administered subcutaneously
Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration
Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
Drug: BG-T187
administered subcutaneously
Phase 1a Part C: Safety Expansion
BG-T187 dose levels that have been determined to be safe and tolerable in Part A will be investigated.
Drug: BG-T187
administered subcutaneously
Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration
Participants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.
Drug: BG-T187
administered subcutaneously
Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents
Participants will receive BG-T187 in combination with Other Therapeutic Agents.
Drug: BG-T187
administered subcutaneously
Other Therapeutic Agents
administered intravenously
Interventions
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Drug: BG-T187
administered subcutaneously
Other Therapeutic Agents
administered intravenously
Eligibility Criteria
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Inclusion Criteria
2. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in 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 Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.
6. Adequate organ function.
Exclusion Criteria
2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
3. Any malignancy ≤ 3 years before the first dose of study drug(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).
4. History of interstitial lung disease (ILD) or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
6. Active hepatitis C.
7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Hackensack University Medical Center
Hackensack, New Jersey, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Next Virginia
Fairfax, Virginia, United States
Washington University, St Louis, Division of Oncology
Madison, Wisconsin, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Linyi Peoples Hospital
Linyi, Shandong, China
The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch
Hangzhou, Zhejiang, China
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Countries
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Central Contacts
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Study Director
Role: CONTACT
Other Identifiers
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2024-514944-10-00
Identifier Type: CTIS
Identifier Source: secondary_id
BG-T187-101
Identifier Type: -
Identifier Source: org_study_id
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