RecruitingPhase 1NCT05279300

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

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

Sponsor

CStone Pharmaceuticals

Enrollment

480 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Advanced Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called CS5001 — alone or combined with other treatments — in patients with advanced solid tumors or lymphomas (blood cancers) that have stopped responding to standard therapies. CS5001 targets a protein called ROR1 found on certain cancer cells. **You may be eligible if...** - You are 18 or older with an advanced solid tumor or B-cell lymphoma that has progressed on standard treatment - For solid tumor patients: your tumor tests positive for the ROR1 protein - Your cancer is not curable with local treatment - Your overall health and organ function are reasonably good **You may NOT be eligible if...** - You have active, untreated brain metastases - You have an autoimmune disease or immune deficiency requiring steroids - You have significant heart disease or active infection - You are HIV positive or have active hepatitis - You are pregnant or breastfeeding - You received cancer treatment within the past 3 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCS5001

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

BIOLOGICALRituximab

IV infusion

DRUGGemcitabine

IV infusion

DRUGOxaliplatin

IV infusion

DRUGLenalidomide

DRUGCyclophosphamide

IV infusion

DRUGDoxorubicin

IV infusion

DRUGVincristine

IV infusion

DRUGPrednisone

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

View Full Details on ClinicalTrials.gov

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NCT05279300

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