A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors

Официальное название

A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors

Обзор

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).

Вмешательства

• Препарат BG-C0979
  Administered by intravenous infusion.
• Препарат Tislelizumab
  Administered by intravenous infusion.

Первичные конечные точки

• Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [Срок оценки: Up to approximately 24 months]
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy [Срок оценки: Up to approximately 10 months]
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) [Срок оценки: Up to approximately 10 months]
• Phase 1b: Recommended Phase 2 Dose (RP2D) [Срок оценки: Up to approximately 24 months]
• Phase 1b: Overall Response Rate (ORR) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (12)

• Phase 1a: ORR [Срок оценки: Up to approximately 24 months]
• Phase 1a and 1b: Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Phase 1a and 1b: Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Phase 1a: Plasma Concentration of BG-C0979 [Срок оценки: Up to approximately 3 months]
• Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979 [Срок оценки: Up to approximately 3 months]
• Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979 [Срок оценки: Up to approximately 3 months]
• Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979 [Срок оценки: Up to approximately 3 months]
• Phase 1b: Number of Participants Experiencing Adverse Events (AEs) [Срок оценки: Up to approximately 24 months]
• Phase 1b: Progression-Free Survival [Срок оценки: Up to approximately 24 months]
• Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC [Срок оценки: Up to approximately 24 months]
• Prostate-Specific Antigen (PSA) Response for Participants with CRPC [Срок оценки: Up to approximately 24 months]
• Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab [Срок оценки: Up to approximately 3 months]

Критерии участия

Критерии включения

• Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
• Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
• Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
• Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
• Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have adequate organ function.

Критерии исключения

• Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

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 · 6 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Чунцин
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Фучжоу
• Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Гуанчжоу
• Yichang Central Peoples Hospital — Yichang
• Fudan University Shanghai Cancer Centerpudong — Шанхай

Австралия · 4 центра

• Northern Beaches Hospital — Frenchs Forest
• Liverpool Hospital — Liverpool
• Icon Cancer Centre South Brisbane — South Brisbane
• Cabrini Hospital Malvern — Malvern

Испания · 4 центра

• Hospital Universitario Vall Dhebron — Barcelona
• Hospital Clinic de Barcelona — Barcelona
• Hospital Universitario Fundacion Jimenez Diaz — Madrid
• Next Oncology Madrid — Madrid

США · 3 центра

• Washington University School of Medicine — St Louis
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack
• Next Oncology San Antonio — San Antonio

Идентификаторы

NCT: NCT07414836 · BG-C0979-101 · 2025-524857-15-00 · CTR20261327

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20261327 (платформа chinadrugtrials.org.cn)

Открыть это исследование на ClinicalTrials.gov ↗