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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-18

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Drug: BG-T187

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Drug: BG-T187

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Drug: BG-T187

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Drug: BG-T187

Intervention Type DRUG

administered subcutaneously

Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents

Participants will receive BG-T187 in combination with Other Therapeutic Agents.

Group Type EXPERIMENTAL

Drug: BG-T187

Intervention Type DRUG

administered subcutaneously

Other Therapeutic Agents

Intervention Type DRUG

administered intravenously

Interventions

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Drug: BG-T187

administered subcutaneously

Intervention Type DRUG

Other Therapeutic Agents

administered intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Next Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Washington University, St Louis, Division of Oncology

Madison, Wisconsin, United States

Site Status RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Site Status RECRUITING

Macquarie University

North Ryde, New South Wales, Australia

Site Status RECRUITING

Cabrini Hospital Malvern

Malvern East, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

The Sixth Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Linyi Peoples Hospital

Linyi, Shandong, China

Site Status RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch

Hangzhou, Zhejiang, China

Site Status RECRUITING

Seoul National University Bundang Hospital

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Site Status RECRUITING

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, South Korea

Site Status RECRUITING

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Countries

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United States Australia China South Korea

Central Contacts

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Study Director

Role: CONTACT

1.877.828.5568

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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