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NCT06596473
Un estudio de BG-C477 en participantes con tumores sólidos avanzados.
Reclutando
Fase 1
Descripción
El objetivo de este estudio es evaluar la seguridad, la tolerabilidad, la farmacocinética, la farmacodinámica y la actividad antitumoral preliminar de BG-C477, tanto en monoterapia como en combinación con agentes antineoplásicos, en participantes con tumores sólidos avanzados seleccionados.
Criterios de Elegibilidad
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Información del Ensayo
NCT06596473
Reclutando
Fase 1
310 participantes
Oct 2024
Dic 2027
Ubicaciones52
Australia (6)
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148 Reclutando
Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086 Reclutando
Sunshine Coast University Private Hospital
Birtinya, Queensland, QLD 4575 Reclutando
Cancer Research South Australia
Adelaide, South Australia, SA 5000 Reclutando
The Alfred Hospital
Melbourne, Victoria, VIC 3004 Reclutando
One Clinical Research
Nedlands, Western Australia, WA 6009 Reclutando
China (26)
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149 Reclutando
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021 Reclutando
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030 Reclutando
Fujian Cancer Hospital
Fuzhou, Fujian, 350014 Reclutando
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515 Reclutando
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060 Reclutando
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 530201 Reclutando
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000 Reclutando
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, 154004 Reclutando
Henan Cancer Hospital
Zhengzhou, Henan, 450000 Reclutando
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052 Reclutando
Hubei Cancer Hospital
Wuhan, Hubei, 430079 Reclutando
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029 Reclutando
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006 Reclutando
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029 Reclutando
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000 Reclutando
The First Hospital of China Medical University
Shenyang, Liaoning, 110001 Reclutando
Jining No1 Peoples Hospital East Branch
Jining, Shandong, 272002 Reclutando
Linyi Peoples Hospital Beicheng Branch
Linyi, Shandong, 276005 Reclutando
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433 Reclutando
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041 Reclutando
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060 Reclutando
Yunnan Cancer Hospital
Kunming, Yunnan, 650100 Reclutando
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002 Reclutando
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, 317004 Reclutando
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000 Reclutando
Japan (2)
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191 Reclutando
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550 Reclutando
Malaysia (5)
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
Kota Kinabalu Sabah, 88996 Reclutando
Hospital Kuala Lumpur
Kuala Lumpur, 50586 Reclutando
Sarawak General Hospital
Kuching, 93586 Reclutando
Sunway Medical Centre
Petaling Jaya, 47500 Reclutando
National Cancer Institute (Institut Kanser Negara)
Putrajaya, 62250 Reclutando
New Zealand (1)
Auckland City Hospital
Auckland, 1023 Reclutando
Thailand (3)
Siriraj Hospital
Bangkok, 10700 Reclutando
Srinagarind Hospital (Khon Kaen University)
Muang, 40002 Reclutando
King Chulalongkorn Memorial Hospital (Chulalongkorn University)
Pathum Wan, 10330 Reclutando
United States (9)
City of Hope Phoenix Cancer Center
Goodyear, Arizona, 85338 Reclutando
City of Hope National Medical Center
Duarte, California, 91010-3012 Reclutando
University of Colorado Cancer Center
Aurora, Colorado, 80045-2517 Reclutando
Yale University Yale Cancer Center
New Haven, Connecticut, 06520-8028 Reclutando
Osf Saint Francis Medical Center
Peoria, Illinois, 61637 Reclutando
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003 Reclutando
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601 Reclutando
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009 Reclutando
Texas Oncology Longview
Longview, Texas, 75601 Reclutando