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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05279300
Registration number
NCT05279300
Ethics application status
Date submitted
4/03/2022
Date registered
15/03/2022
Date last updated
29/03/2024
Titles & IDs
Public title
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
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Scientific 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
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Secondary ID [1]
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CS5001-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Advanced Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CS5001
Experimental: Dose escalation -
Experimental: Dose expansion -
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
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Assessment method [1]
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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).
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Timepoint [1]
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About 6 months
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Primary outcome [2]
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Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
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Assessment method [2]
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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.
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Timepoint [2]
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About 6 months
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Primary outcome [3]
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Incident and severity of adverse events
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Assessment method [3]
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Timepoint [3]
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Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
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Secondary outcome [1]
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Concentration of CS5001 total antibody, prodrug and the free cytotoxin
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Assessment method [1]
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Timepoint [1]
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Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
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Secondary outcome [2]
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Concentration of anti-CS5001 antibodies
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Assessment method [2]
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Timepoint [2]
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Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
156
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Scientia Clinical Research Limited - Randwick
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Recruitment hospital [2]
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Ashford Cancer Centre Research - Adelaide
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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China
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State/province [3]
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Anhui
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Country [4]
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China
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State/province [4]
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Guangdong
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Country [5]
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China
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State/province [5]
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Henan
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Country [6]
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China
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State/province [6]
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Hubei
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Country [7]
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China
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State/province [7]
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Shandong
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Country [8]
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China
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State/province [8]
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Shanghai
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Country [9]
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China
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State/province [9]
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Zhejiang
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Country [10]
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China
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State/province [10]
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Beijing
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CStone Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05279300
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Crystal Wang
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Address
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Country
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Phone
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021-60332435
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05279300
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