A Study of BG-C477 in Participants With Advanced Solid Tumors
Phase 1 – testing safety in a small group of people
Conditions:
Advanced Solid Tumors
Sponsor: BeOne Medicines
trial.available_in:
БГ
Overview
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.
Description
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.
Who can participate
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.
Interventions
BG-C477
DRUG
Tislelizumab
DRUG
Chemotherapy
DRUG
Locations
32
Australia (6)
Cancer Research South Australia
Adelaide , South Australia
Sunshine Coast University Private Hospital
Birtinya , Queensland
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
Northern Beaches Hospital
Frenchs Forest , New South Wales
The Alfred Hospital
Melbourne , Victoria
One Clinical Research
Nedlands , Western Australia
China (18)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing , Beijing Municipality
Beijing Chest Hospital, Capital Medical University
Beijing , Beijing Municipality
Chongqing University Cancer Hospital
Chongqing , Chongqing Municipality
Fujian Cancer Hospital
Fuzhou , Fujian
Sun Yat Sen University Cancer Center
Guangzhou , Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou , Guangdong
Jiamusi Cancer Hospital
Jiamusi , Heilongjiang
Jining No1 Peoples Hospital East Branch
Jining , Shandong
Yunnan Cancer Hospital
Kunming , Yunnan
Linyi Peoples Hospital Beicheng Branch
Linyi , Shandong
Jiangxi Cancer Hospital
Nanchang , Jiangxi
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang , Jiangxi
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning , Guangxi
The First Affiliated Hospital of Soochow University
Suzhou , Jiangsu
Taizhou Hospital of Zhejiang Province (East)
Taizhou , Zhejiang
Tianjin Medical University Cancer Institute and Hospital
Tianjin , Tianjin Municipality
Hubei Cancer Hospital
Wuhan , Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou , Henan
Japan (1)
Kansai Medical University Hospital
Hirakata , Osaka
New Zealand (1)
Auckland City Hospital
Auckland
United States (6)
City of Hope National Medical Center
Duarte , California
City of Hope Phoenix Cancer Center
Goodyear , Arizona
John Theurer Cancer Center Hackensack University Medical Center