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
1 other identifier
interventional
480
3 countries
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Longer than P75 for phase_1
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 11, 2025
August 1, 2025
5.3 years
March 4, 2022
August 6, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Participants will receive CS5001 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT).
About 6 months
Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range.
About 6 months
Incident and severity of adverse events
Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Objective Response Rate (ORR) (for dose expansion)
The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors.
Up to 2 years
Secondary Outcomes (2)
Concentration of CS5001 total antibody
Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Concentration of anti-CS5001 antibodies
Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Other Outcomes (1)
Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part)
About up to 12 months
Study Arms (2)
Dose escalation
EXPERIMENTALDose expansion
EXPERIMENTALInterventions
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 15, 2022
Study Start
March 28, 2022
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share