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

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

Overview

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

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.

Interventions

• Drug Drug: BG-T187
  administered subcutaneously
• Drug Other Therapeutic Agents
  administered intravenously

Primary outcome measures

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 2 years]
• Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187 [Time frame: Approximately 2 years]
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187 [Time frame: Approximately 2 years]
• Phase 1b: Overall Response Rate (ORR) [Time frame: Approximately 2 years]
• Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents [Time frame: Approximately 2 years]

Secondary outcome measures (9)

• Phase 1a: ORR [Time frame: Approximately 2 years]
• Phase 1a and 1b: Duration of Response (DOR) [Time frame: Approximately 2 years]
• Phase 1a and 1b: Disease Control Rate (DCR) [Time frame: Approximately 2 years]
• Phase 1b: Progression Free Survival (PFS) [Time frame: Approximately 2 years]
• Phase 1a: Maximum observed plasma concentration (Cmax) of BG-T187 [Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)]
• Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187 [Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)]
• Phase 1a: Terminal Half-Life (t1/2) of BG-T187 [Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)]
• Phase 1a: Time to maximum plasma concentration (Tmax) of BG-T187 [Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)]
• Phase 1b: Number of Participants with AEs and SAEs [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 15 centers

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing
• Chongqing University Cancer Hospital — Chongqing
• Fujian Cancer Hospital — Fuzhou
• Fujian Medical University Union Hospitalqishan Branch — Fuzhou
• The Sixth Affiliated Hospital, Sun Yat Sen University — Guangzhou
• Guangxi Medical University Cancer Hospital — Nanning
• Harbin Medical University Cancer Hospital — Harbin
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan
• … and 7 more centers

South Korea · 7 centers

• The Catholic University of Korea, St Vincents Hospital — PaldalGu SuwonSi
• Seoul National University Bundang Hospital — Seongnam-si
• Samsung Medical Center — GangnamGu
• The Catholic University of Korea, Seoul St Marys Hospital — SeochoGu
• Severance Hospital Yonsei University Health System — SeodaemunGu
• Seoul National University Hospital — Seoul
• Asan Medical Center — SongpaGu

United States · 4 centers

• Hackensack University Medical Center — Hackensack
• The University of Texas Md Anderson Cancer Center — Houston
• Next Virginia — Fairfax
• Washington University, St Louis, Division of Oncology — Madison

Australia · 4 centers

• Blacktown Cancer and Haematology Centre — Blacktown
• Macquarie University — North Ryde
• Cabrini Hospital Malvern — Malvern
• Linear Clinical Research — Nedlands

Identifiers

NCT: NCT06598800 · BG-T187-101 · 2024-514944-10-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗