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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05279300




Registration number
NCT05279300
Ethics application status
Date submitted
4/03/2022
Date registered
15/03/2022

Titles & IDs
Public title
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
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
Secondary ID [1] 0 0
CS5001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Advanced Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Timepoint [1] 0 0
About 6 months
Primary outcome [2] 0 0
Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
Timepoint [2] 0 0
About 6 months
Primary outcome [3] 0 0
Incident and severity of adverse events
Timepoint [3] 0 0
Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
Secondary outcome [1] 0 0
Concentration of CS5001 total antibody, prodrug and the free cytotoxin
Timepoint [1] 0 0
Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first
Secondary outcome [2] 0 0
Concentration of anti-CS5001 antibodies
Timepoint [2] 0 0
Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Scientia Clinical Research Limited - Randwick
Recruitment hospital [2] 0 0
Ashford Cancer Centre Research - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
China
State/province [3] 0 0
Anhui
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Guangxi
Country [7] 0 0
China
State/province [7] 0 0
Henan
Country [8] 0 0
China
State/province [8] 0 0
Hubei
Country [9] 0 0
China
State/province [9] 0 0
Shandong
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
China
State/province [11] 0 0
Zhejiang

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CStone Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Crystal Wang
Address 0 0
Country 0 0
Phone 0 0
021-60332435
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05279300