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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 15 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Chongqing University Cancer Hospital — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Fujian Medical University Union Hospitalqishan Branch — Фучжоу
• The Sixth Affiliated Hospital, Sun Yat Sen University — Гуанчжоу
• Guangxi Medical University Cancer Hospital — Nanning
• Harbin Medical University Cancer Hospital — Харбин
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Ухань
• … и ещё 7 центров

South Korea · 7 центров

• 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

США · 4 центра

• 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

Австралия · 4 центра

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗