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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05279300
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Advanced Lymphoma Drug: CS5001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05279300


Contacts
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Contact: Ada Chen 021-60332435 chenli@cstonepharma.com

Locations
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United States, New York
North Shore Hematology Oncology Associates Recruiting
East Setauket, New York, United States, 11733
Contact: Zuniga Richard    631-675-5075    Research@nycancer.com   
Columbia U. - Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Richard Carvajal    212-305-8602    cancerclinicaltrials@cumc.columbia.edu   
United States, Texas
BUMC - Mary Crowley Cancer Research Centers (MCCRC) Recruiting
Dallas, Texas, United States, 75201-7307
Contact: Barve Minal    972-566-3000    Referral@MaryCrowley.org   
Australia, New South Wales
Scientia Clinical Research Limited Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Charlotte Lemech    61 02 9382 5800    charlotte.lemech@scientiaclinicalresearch.com.au   
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Adelaide, South Australia, Australia
Contact: Sarwan Bishnoi    08 8292 2220    sarwan.bishnoi@icon.team   
China, Henan
Henan Cancer Hospital Not yet recruiting
Zhengzhou, Henan, China
Principal Investigator: Keshu Zhou         
China, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Principal Investigator: Liling Zhang         
China
Beijing Cancer Hospital Recruiting
Beijing, China
Principal Investigator: Yuqing Song         
Beijing Cancer Hospital Recruiting
Beijing, China
Principal Investigator: Lin Shen         
Fudan University Shanghai Cancer Hospital Recruiting
Shanghai, China
Principal Investigator: Jian Zhang         
Sponsors and Collaborators
CStone Pharmaceuticals
More Information
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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05279300    
Other Study ID Numbers: CS5001-101
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases