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Advanced Solid TumorPhase 1NCT06598800

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

A Phase 1 study testing Drug: BG-T187 and Other Therapeutic Agents in people with Advanced Solid Tumor, run by BeOne Medicines at 34 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Drug: BG-T187 and Other Therapeutic Agents
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
34 sitesin 4 countries
Study dates
18 Oct 2024to 30 Sep 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  • Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC).
  • ≥ 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.
  • Adequate organ function.

Who cannot join

  • Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
  • Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
  • 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).
  • 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.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
  • Active hepatitis C.
  • 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).
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

34 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

34 sites in 4 countries

China19 sites, 19 recruiting
  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting
  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting
  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting
  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting
  • Fujian Medical University Union Hospitalqishan Branch

    Fuzhou, Fujian, 350108

    Recruiting
  • The Sixth Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510655

    Recruiting
  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch

    Hangzhou, Zhejiang, 310024

    Recruiting
  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting
  • Linyi Peoples Hospital

    Linyi, Shandong, 276000

    Recruiting
  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, 332000

    Recruiting
  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

    Recruiting
  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

    Recruiting
  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

    Recruiting
  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Recruiting
  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

    Recruiting
  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430030

    Recruiting
  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Recruiting

Other trials in China

South Korea7 sites, 7 recruiting
  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Recruiting
  • The Catholic University of Korea, St Vincents Hospital

    PaldalGu SuwonSi, Gyeonggi-do, 16247

    Recruiting
  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

    Recruiting
  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Recruiting
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting
  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting
  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

    Recruiting

Other trials in South Korea

United States4 sites, 4 recruiting
  • Next Oncology Virginia

    Fairfax, Virginia, 22031

    Recruiting
  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1915

    Recruiting
  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting
  • Washington University, St Louis, Division of Oncology

    Madison, Wisconsin, 53708-8056

    Recruiting

Other trials in United States

Australia4 sites, 4 recruiting
  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

    Recruiting
  • Cabrini Hospital Malvern

    Malvern, Victoria, VIC 3144

    Recruiting
  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting
  • Macquarie University

    North Ryde, New South Wales, NSW 2109

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

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.

Read the detailed description

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.

Being tested
Drug: BG-T187, Other Therapeutic Agents
Keywords
Advanced Solid Tumors, First-in-human, BG-T187, EGFR, c-MET

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: BG-T187Drug

    administered subcutaneously

  • Other Therapeutic AgentsDrug

    administered intravenously

Study groups in NCT06598800
Study groupRoleWhat they receive
Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous AdministrationExperimentalSequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
Receives: Drug: Drug: BG-T187
Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous AdministrationExperimentalSequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
Receives: Drug: Drug: BG-T187
Phase 1a Part C: Safety ExpansionExperimentalBG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated.
Receives: Drug: Drug: BG-T187
Phase 1b: Monotherapy Dose Expansion with Subcutaneous AdministrationExperimentalParticipants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.
Receives: Drug: Drug: BG-T187
Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic AgentsExperimentalParticipants will receive BG-T187 in combination with Other Therapeutic Agents.
Receives: Drug: Drug: BG-T187; Drug: Other Therapeutic Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome [CRS] and immune effector cell associated neurotoxicity syndrome [ICANS]); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Measured: Approximately 2 years

  2. Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187

    MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively.

    Measured: Approximately 2 years

  3. Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187

    RDFE(s) is determined based on the MAD or MTD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available

    Measured: Approximately 2 years

  4. Phase 1b: Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Approximately 2 years

  5. Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents

    R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available

    Measured: Approximately 2 years

Secondary outcomes (9)
  1. Phase 1a: ORR

    ORR is defined as the percentage of participants with confirmed BOR, CR or PR as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Approximately 2 years

  2. Phase 1a and 1b: Duration of Response (DOR)

    DOR is defined as the time from the first objective response until the first documentation of disease progression after treatment initiation or death, whichever comes first, as determined by investigators per RECIST v1.1

    Measured: Approximately 2 years

  3. Phase 1a and 1b: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with the BOR of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1

    Measured: Approximately 2 years

  4. Phase 1b: Progression Free Survival (PFS)

    PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1

    Measured: Approximately 2 years

  5. Phase 1a: Maximum observed plasma concentration (Cmax) of BG-T187

    Measured: From Cycle 1 to Cycle 3 (each cycle is 28 days)

  6. Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187

    Measured: From Cycle 1 to Cycle 3 (each cycle is 28 days)

  7. Phase 1a: Terminal Half-Life (t1/2) of BG-T187

    Measured: From Cycle 1 to Cycle 3 (each cycle is 28 days)

  8. Phase 1a: Time to maximum plasma concentration (Tmax) of BG-T187

    Measured: From Cycle 1 to Cycle 3 (each cycle is 28 days)

  9. Phase 1b: Number of Participants with AEs and SAEs

    Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT)

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start18 Oct 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598800
Sponsor's protocol ID
BG-T187-101
Other IDs
2024-514944-10-00
Status last verified
Sep 2026
First submitted
12 Sep 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: BG-T187 and Other Therapeutic Agents in people with Advanced Solid Tumor, run by BeOne Medicines at 34 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, South Korea, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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