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

August 6, 2025 updated by: CStone Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
    • South Australia
      • Adelaide, South Australia, Australia
        • Terminated
        • Ashford Cancer Centre Research
      • Adelaide, South Australia, Australia
        • Recruiting
        • Central Adelaide Local Health Network Incorporated
        • Principal Investigator:
          • Pratyush Giri
      • Adelaide, South Australia, Australia
        • Recruiting
        • Royal Adelaide Hospital (RAH)
        • Contact:
    • Victoria
      • East Melbourne, Victoria, Australia
      • Melbourne, Victoria, Australia
        • Not yet recruiting
        • Epworth Foundation Trading as Epworth HealthCare
        • Principal Investigator:
          • Costas Yannakou
  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Principal Investigator:
          • Kaiyang DING
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hospital,
        • Principal Investigator:
          • Yueyin Pan
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Yuqing Song
      • Beijing, Beijing, China
        • Terminated
        • Beijing Cancer Hospital
      • Beijing, Beijing, China
        • Not yet recruiting
        • Yanda Lu Dao Pei Hospital
        • Principal Investigator:
          • Peihua Lu
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The Cancer Hospital Affiliated to Chongqing University
        • Principal Investigator:
          • Yao Liu
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Ying Chen
    • Guang Dong
      • Guangzhou, Guang Dong, China
        • Not yet recruiting
        • Sun Yatsen University Cancer Center
        • Principal Investigator:
          • Mingzhi Li
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Province Hospital
        • Principal Investigator:
          • Wenyu Li
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Affiliated Tumour Hospital
        • Principal Investigator:
          • Hong Cen
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Haisheng LIU
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Keshu Zhou
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Principal Investigator:
          • Zunmin Zhu
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Principal Investigator:
          • Xinjun Liang
        • Principal Investigator:
          • Huijing Wu
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Principal Investigator:
          • Liling Zhang
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer hospital
        • Principal Investigator:
          • Yajun Li
    • Jiang Su
      • Suzhu, Jiang Su, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Caixia Li
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Lei FAN
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Principal Investigator:
          • Yan Huang
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Principal Investigator:
          • Man Li
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Pengcheng He
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Principal Investigator:
          • Yan Zhang
        • Principal Investigator:
          • Linna Xie
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • Ye Guo
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Hospital
        • Principal Investigator:
          • Jian Zhang
      • Shanghai, Shanghai, China
        • Terminated
        • Shanghai Pulmonary Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Liping Su
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Principal Investigator:
          • Shuhua Yi
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Yunnan Cancer Hospital
        • Principal Investigator:
          • Xiaopei Wang
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • He Huang
  • United States
    • New York
      • East Setauket, New York, United States, 11733
        • Recruiting
        • North Shore Hematology Oncology Associates
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia U. - Herbert Irving Comprehensive Cancer Center
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75201-7307
        • Recruiting
        • BUMC - Mary Crowley Cancer Research Centers (MCCRC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation
Drug: CS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Experimental: Dose expansion
Drug: Gemcitabine
IV infusion
Drug: Oxaliplatin
IV infusion
Biological: Rituximab
IV infusion
Drug: Cyclophosphamide
IV infusion
Drug: Doxorubicin
IV infusion
Drug: Prednisone
PO
Drug: Vincristine
IV infusion
Drug: CS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Drug: Lenalidomide
PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Time Frame: About 6 months
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)
Time Frame: About 6 months
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
Time Frame: Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
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)
Time Frame: Up to 2 years
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 Outcome Measures

Outcome Measure
Time Frame
Concentration of anti-CS5001 antibodies
Time Frame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Concentration of CS5001 total antibody
Time Frame: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first

Other Outcome Measures

Outcome Measure
Time Frame
Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part)
Time Frame: About up to 12 months
About up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CStone Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS5001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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