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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Drug: BG-T187; Drug: Other Therapeutic Agents

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.

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director
• Study Contact Backup: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Cancer and Haematology Centre
    • North Ryde, New South Wales, Australia, NSW 2109
      • Recruiting
      • Macquarie University
  • Victoria
    • Malvern, Victoria, Australia, VIC 3144
      • Recruiting
      • Cabrini Hospital Malvern
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • Linear Clinical Research
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Recruiting
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat Sen University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Guangxi Medical University Cancer Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Shandong
    • Linyi, Shandong, China, 276000
      • Recruiting
      • Linyi Peoples Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch
• South Korea
  • Gyeonggi-do
    • PaldalGu SuwonSi, Gyeonggi-do, South Korea, 16247
      • Recruiting
      • The Catholic University of Korea, St Vincents Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center
• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601-1915
      • Recruiting
      • Hackensack University Medical Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Virginia
  • Wisconsin
    • Madison, Wisconsin, United States, 53708-8056
      • Recruiting
      • Washington University, St Louis, Division of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC).
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).

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: Drug: BG-T187; administered subcutaneously
Experimental: 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: Drug: BG-T187; administered subcutaneously
Experimental: 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: Drug: BG-T187; administered subcutaneously
Experimental: Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents; Participants will receive BG-T187 in combination with Other Therapeutic Agents.	Drug: Drug: BG-T187; administered subcutaneously; Drug: Other Therapeutic Agents; administered intravenously
Experimental: Phase 1a Part C: Safety Expansion; BG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated.	Drug: Drug: BG-T187; administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Approximately 2 years
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	Approximately 2 years
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	Approximately 2 years
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	Approximately 2 years
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.	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Approximately 2 years
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	Approximately 2 years
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	Approximately 2 years
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)	Approximately 2 years
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	Approximately 2 years
Phase 1a: Maximum observed plasma concentration (Cmax) of BG-T187		From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187		From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1a: Terminal Half-Life (t1/2) of BG-T187		From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1a: Time to maximum plasma concentration (Tmax) of BG-T187		From Cycle 1 to Cycle 3 (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: EGFR; Advanced Solid Tumors; First-in-human; c-MET; BG-T187
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BG-T187-101; 2024-514944-10-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No