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RECRUITING
NCT05279300
PHASE1

A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas

Sponsor: CStone Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

CS5001

The dose and dosing schedule is decided by the Safety Monitoring Committee.

BIOLOGICAL

Rituximab

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Oxaliplatin

IV infusion

DRUG

Lenalidomide

PO

DRUG

Cyclophosphamide

IV infusion

DRUG

Doxorubicin

IV infusion

DRUG

Vincristine

IV infusion

DRUG

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