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

NCT06598800 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: BG-T187-1012024-514944-10-00
• Study Type: interventional
• Target: 153
• Locations: 4 countries
• Sites: 26

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumors; First-in-human; BG-T187; EGFR; c-MET

Outcome Measures

Primary Outcomes (5)

• 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: 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

• 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

Secondary Outcomes (9)

• Phase 1a: ORR

  Approximately 2 years

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

  Approximately 2 years

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

  Approximately 2 years

• Phase 1b: Progression Free Survival (PFS)

  Approximately 2 years

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

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

Study Arms (5)

Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

Drug: Drug: BG-T187

Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

Drug: Drug: BG-T187

Phase 1a Part C: Safety Expansion

EXPERIMENTAL

BG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated.

Drug: Drug: BG-T187

Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration

EXPERIMENTAL

Participants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.

Drug: Drug: BG-T187

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

EXPERIMENTAL

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

Drug: Drug: BG-T187; Drug: Other Therapeutic Agents

Interventions

Drug: BG-T187 DRUG

administered subcutaneously

Phase 1a Part C: Safety Expansion; Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration; Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration; Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents; Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration

Other Therapeutic Agents DRUG

administered intravenously

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (26)

Hackensack University Medical Center

Hackensack, New Jersey, 07601-1915, United States

RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Washington University, St Louis, Division of Oncology

Madison, Wisconsin, 53708-8056, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Macquarie University

North Ryde, New South Wales, NSW 2109, Australia

RECRUITING

Cabrini Hospital Malvern

Malvern East, Victoria, VIC 3144, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

The Sixth Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Linyi Peoples Hospital

Linyi, Shandong, 276000, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch

Hangzhou, Zhejiang, 310024, China

RECRUITING

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Director

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (4); CN (11); KR (7); AU (4)