Chemotherapy: Administered in accordance with relevant local guidelines and/or prescribing information.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years) Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) criteria.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) — Approximately 1 year MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477 — Approximately 1 year RDFE of BG-C477 monotherapy will be determined based upon available data.
Phase 1b: Overall Response Rate (ORR) — Approximately 2 years ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477 — Approximately 2 years RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
Trial sites (59)
Facility
City
Region
Status
City of Hope Phoenix Cancer Center
Goodyear
Arizona
Recruiting
City of Hope National Medical Center
Duarte
California
Recruiting
University of Colorado Cancer Center
Aurora
Colorado
Recruiting
Yale University Yale Cancer Center
New Haven
Connecticut
Recruiting
Osf Saint Francis Medical Center
Peoria
Illinois
Recruiting
The University of Kansas Cancer Center
Westwood
Kansas
Recruiting
University of Mississippi Medical Center (Ummc)
Jackson
Mississippi
Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack
New Jersey
Recruiting
The University of Texas Md Anderson Cancer Center
Houston
Texas
Recruiting
Texas Oncology Longview
Longview
Texas
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
Recruiting
Northern Beaches Hospital
Frenchs Forest
New South Wales
Recruiting
Sunshine Coast University Private Hospital
Birtinya
Queensland
Recruiting
Cancer Research South Australia
Adelaide
South Australia
Recruiting
The Alfred Hospital
Melbourne
Victoria
Recruiting
One Clinical Research
Nedlands
Western Australia
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Sun Yat Sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Guangdong
Recruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning
Guangxi
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Jiamusi Cancer Hospital
Jiamusi
Heilongjiang
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Recruiting
Jiangxi Cancer Hospital
Nanchang
Jiangxi
Recruiting
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang
Jiangxi
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Jining No1 Peoples Hospital East Branch
Jining
Shandong
Recruiting
Linyi Peoples Hospital Beicheng Branch
Linyi
Shandong
Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou
Zhejiang
Recruiting
+ 19 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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