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

March 28, 2024 updated by: CStone Pharmaceuticals

A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, 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 in patients with advanced hematological and solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

156

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
        • Recruiting
        • Ashford Cancer Centre Research
        • Contact:
  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Lin Shen
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Hospital
        • Principal Investigator:
          • Jian Zhang
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hospital,
        • Principal Investigator:
          • Yueyin Pan
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Province Hospital
        • Principal Investigator:
          • Wenyu Li
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Keshu Zhou
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Principal Investigator:
          • Liling Zhang
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Principal Investigator:
          • Yan Zhang
        • Principal Investigator:
          • Linna Xie
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Principal Investigator:
          • Caicun Zhou
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • Caicun Zhou
    • 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 dose expansion, pathologically confirmed Mantle Cell Lymphoma(MCL, following at least two prior lines of systemic therapy including Bruton Tyrosine Kinase inhibitors), Diffuse Large B Cell Lymphoma(DLBCL, following at least two prior lines of systemic therapies), and Triple Negative Breast Cancer(TNBC, following at least 2 lines of systemic therapy for advanced disease) will be enrolled.
  • 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 or 1.
  • Have adequate organ function.
  • Is willing to provide tumor tissue and control blood sample.
  • Female subjects of childbearing potential must have a negative serum pregnancy test.
  • Both male and female subjects must be willing to use adequate contraception.

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
CS5001 will be administered every 3 weeks (21 days) by intravenous (IV) infusion, and 3 weeks (21 days) is considered as one treatment cycle.
Experimental: Dose expansion
Drug: CS5001
CS5001 will be administered every 3 weeks (21 days) by intravenous (IV) infusion, and 3 weeks (21 days) is considered as one treatment cycle.

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of CS5001 total antibody, prodrug and the free cytotoxin
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 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

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)

March 30, 2025

Study Completion (Estimated)

June 30, 2025

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)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

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

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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