A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

Официальное название

A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

Обзор

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).

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 BG-C137
  Administered intravenously
• Препарат Anticancer Agents
  Administered intravenously or orally

Первичные конечные точки

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 2 years]
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137 [Срок оценки: Up to approximately 2 years]
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agents [Срок оценки: Up to approximately 2 years]
• Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137 [Срок оценки: Up to approximately 2 years]
• Phase 1b: Overall Response Rate (ORR) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

• Phase 1a: ORR [Срок оценки: Up to approximately 2 years]
• Phase 1a and 1b: Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
• Phase 1a and 1b: Duration of Response (DOR) [Срок оценки: Up to approximately 2 years]
• Phase 1b: Progression Free Survival (PFS) [Срок оценки: Up to approximately 2 years]
• Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 2 years]
• Phase 1a: Plasma concentrations of BG-C137 analytes [Срок оценки: Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)]
• Phase 1b: Plasma concentrations of BGB-C137 analytes [Срок оценки: Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)]
• Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-C137 analytes [Срок оценки: Twice in the first 3 months]
• Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-C137 analytes [Срок оценки: Twice in the first 3 months]
• Phase 1a: Minimum Observed Plasma Concentration (Ctrough) Of BGB-C137 analytes [Срок оценки: Twice in the first 3 months]
• Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BGB-C137 analytes [Срок оценки: Twice in the first 3 months]
• Phase 1a: Terminal Half-Life (t1/2) of BGB-C137 analytes [Срок оценки: Twice in the first 3 months]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed advanced or metastatic solid tumors.
• Life expectancy of ≥ 3 months.
• Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and/or a platinum in the advanced or metastatic setting
• Tumors with FGFR2b expression/ or FGFR2 gene amplification. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.
• ≥ 1 measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate organ function as determined per protocol.

Критерии исключения

• Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
• Active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
• Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \[whichever is shorter\] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).
• Toxicities due to prior therapy that have not recovered.
• Any malignancy ≤ 2 years before 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.
• History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline.

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 · 32 центра

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Anhui Provincial Hospital — Хэфэй
• The Second Hospital of Anhui Medical University — Хэфэй
• Beijing Friendship Hospital, Capital Medical University — Пекин
• Beijing Cancer Hospital — Пекин
• Fujian Medical University Union Hospital — Фучжоу
• The First Affiliated Hospital of Xiamen University — Xiamen
• Zhongshan Hospital Xiamen University — Xiamen
• … и ещё 24 центра

South Korea · 9 центров

• Cha Bundang Medical Center, Cha University — BundangGu SeongnamSi
• Seoul National University Bundang Hospital — Seongnam-si
• Kyungpook National University Chilgok Hospital — BukGu
• Gachon University Gil Medical Center — NamdongGu
• Samsung Medical Center — GangnamGu
• Severance Hospital Yonsei University Health System — SeodaemunGu
• Seoul National University Hospital — Seoul
• Gangnam Severance Hospital, Yonsei University Health System — Seoul
• … и ещё 1 центр

США · 6 центров

• Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles
• Yale Cancer Center — New Haven
• Mayo Clinic Rochester — Rochester
• Md Anderson Cancer Center — Houston
• Fred Hutchinson Cancer Research Center — Seattle
• University of Wisconsin — Madison

Австралия · 5 центров

• Blacktown Cancer and Haematology Centre — Blacktown
• Liverpool Hospital — Liverpool
• Icon Cancer Centre South Brisbane — South Brisbane
• Monash Health — Clayton
• Cabrini Hospital Malvern — Malvern

Идентификаторы

NCT: NCT06625593 · BG-C137-101 · 2025-523572-23-00 · CTR20244835

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20244835 (платформа chinadrugtrials.org.cn)

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