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NCT05279300PHASE1Recruiting

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

CStone Pharmaceuticals

Start Date

3/28/2022

Completion Date

12/31/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy. * For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy. * For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed/refractory (R/R) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1/PD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment. * For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. * Life expectancy \> 3 months. * Eastern Cooperative Oncology Group(ECOG) performance status 0-2. * Have adequate organ function. Exclusion Criteria: * Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell transplantation based on the Investigator's judgment. * Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured. * For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and/or during study participation. * Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy. * Has other acute or chronic medical or psychiatric conditions. * Has a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy. * Has peripheral edema, pericardial effusion, or ascites indicated for medical intervention or limiting activity of daily life. Or with a known history of peripheral vasculopathies. * Patients with any active infections requiring systemic therapy within 2 weeks prior to the administration of the first dose of the study drug. * Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS). * Significant cardiovascular disease within 6 months prior to the first dose of the study drug. * Significant screening electrocardiogram (ECG) abnormalities. * Has received major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the administration of the first dose of the study drug. * Administration of a live vaccine within 28 days prior to the administration of the first dose of the study drug. * Has active graft versus host disease. * With known active alcohol or drug abuse. * Women who are pregnant or breastfeeding.

Interventions

DRUG

CS5001

BIOLOGICAL

Rituximab

DRUG

Gemcitabine

DRUG

Oxaliplatin

DRUG

Lenalidomide

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Prednisone

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Conditions

Advanced Solid TumorAdvanced Lymphoma

Locations

North Shore Hematology Oncology Associates

East Setauket, New York 11733

United States

Columbia U. - Herbert Irving Comprehensive Cancer Center

New York, New York 10032

United States

BUMC - Mary Crowley Cancer Research Centers (MCCRC)

Dallas, Texas 75201-7307

United States

Scientia Clinical Research Limited

Randwick, New South Wales 2031

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