A Study of BG-C477 in Participants With Advanced Solid Tumors

Официальное название

A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors

Обзор

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Подробное описание

This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents.

Note: 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 BG-C477
  Administered intravenously.
• Препарат Tislelizumab
  Administered intravenously.
• Препарат Chemotherapy
  Administered in accordance with relevant local guidelines and/or prescribing information.

Первичные конечные точки

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)]
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) [Срок оценки: Approximately 1 year]
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477 [Срок оценки: Approximately 1 year]
• Phase 1b: Overall Response Rate (ORR) [Срок оценки: Approximately 2 years]
• Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477 [Срок оценки: Approximately 2 years]

Вторичные конечные точки (12)

• Phase 1a: ORR [Срок оценки: Approximately 1 year]
• 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 1b: Number of Participants with AEs and SAEs [Срок оценки: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)]
• Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload [Срок оценки: Approximately 2 months]
• Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477 [Срок оценки: Approximately 2 months]
• Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477 [Срок оценки: Approximately 2 months]
• Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477 [Срок оценки: Approximately 2 months]
• Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477 [Срок оценки: Approximately 2 months]
• Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477 [Срок оценки: Approximately 2 months]
• Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477 [Срок оценки: Approximately 2 months]

Критерии участия

Критерии включения

• Participants must sign the informed consent form (ICF) and be capable of giving written informed consent
• Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
• Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator
• Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy
• Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease
• ≥ 1 measurable lesion as assessed by RECIST v1.1
• Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
• Adequate organ function
• Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later
• Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later.

Критерии исключения

• Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
• History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• Any malignancy ≤ 2 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 curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

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 · 26 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Beijing Chest Hospital, Capital Medical University — Пекин
• Chongqing University Cancer Hospital — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Sun Yat Sen University Cancer Center — Гуанчжоу
• Nanfang Hospital, Southern Medical University — Гуанчжоу
• Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning
• Harbin Medical University Cancer Hospital — Харбин
• … и ещё 18 центров

США · 9 центров

• City of Hope Phoenix Cancer Center — Goodyear
• City of Hope National Medical Center — Duarte
• University of Colorado Cancer Center — Aurora
• Yale University Yale Cancer Center — New Haven
• Osf Saint Francis Medical Center — Peoria
• The University of Kansas Cancer Center — Westwood
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack
• The University of Texas Md Anderson Cancer Center — Houston
• … и ещё 1 центр

Австралия · 6 центров

• Blacktown Cancer and Haematology Centre — Blacktown
• Northern Beaches Hospital — Frenchs Forest
• Sunshine Coast University Private Hospital — Birtinya
• Cancer Research South Australia — Adelaide
• The Alfred Hospital — Melbourne
• One Clinical Research — Nedlands

Малайзия · 5 центров

• Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas) — Kota Kinabalu Sabah
• Hospital Kuala Lumpur — Kuala Lumpur
• Sarawak General Hospital — Kuching
• Sunway Medical Centre — Petaling Jaya
• National Cancer Institute (Institut Kanser Negara) — Putrajaya

Япония · 4 центра

• Kansai Medical University Hospital — Hirakata
• Shizuoka Cancer Center — Suntogun
• Tokyo Metropolitan Komagome Hospital — Bunkyoku
• Cancer Institute Hospital of Jfcr — Kotoku

South Korea · 4 центра

• Seoul National University Bundang Hospital — Seongnam-si
• Samsung Medical Center — GangnamGu
• Severance Hospital Yonsei University Health System — SeodaemunGu
• Asan Medical Center — SongpaGu

Таиланд · 3 центра

• Siriraj Hospital — Bangkok
• Srinagarind Hospital (Khon Kaen University) — Muang
• King Chulalongkorn Memorial Hospital (Chulalongkorn University) — Pathum Wan

Новая Зеландия · 1 центр

• Auckland City Hospital — Auckland

Идентификаторы

NCT: NCT06596473 · BG-C477-101 · CTR20244563

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20244563 (платформа chinadrugtrials.org.cn)

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