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A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
Sponsor: CStone Pharmaceuticals
Summary
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.
Official title: A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activities of CS5001, an Anti-ROR1 Antibody-Drug Conjugate, Used as A Single Agent and in Combination With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2022-03-28
Completion Date
2027-12-31
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
CS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Rituximab
IV infusion
Gemcitabine
IV infusion
Oxaliplatin
IV infusion
Lenalidomide
PO
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Vincristine
IV infusion
Prednisone
PO
Locations (38)
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Columbia U. - Herbert Irving Comprehensive Cancer Center
New York, New York, United States
BUMC - Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, United States
Scientia Clinical Research Limited
Randwick, New South Wales, Australia
Ashford Cancer Centre Research
Adelaide, South Australia, Australia
Central Adelaide Local Health Network Incorporated
Adelaide, South Australia, Australia
Royal Adelaide Hospital (RAH)
Adelaide, South Australia, Australia
Epworth Freemasons Medical Centre
East Melbourne, Victoria, Australia
Epworth Foundation trading as Epworth HealthCare
Melbourne, Victoria, Australia
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Hospital,
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Yanda Lu Dao Pei Hospital
Beijing, Beijing Municipality, China
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangdong Province Hospital
Guangzhou, Guangdong, China
Sun YatSen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu province hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China