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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/NCT04233060




Registration number
NCT04233060
Ethics application status
Date submitted
15/01/2020
Date registered
18/01/2020
Date last updated
27/04/2022

Titles & IDs
Public title
A Study of CS3005 in Advanced Solid Tumors
Scientific title
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
CS3005-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CS3005

Experimental: CS3005 -


Treatment: Drugs: CS3005
CS3005 will be orally administrated twice daily (BID) until PD, unacceptable toxicity, withdrawal of informed consent, or until maximum treatment duration per protocol (2 years)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
From the day of first dose to 30 days (±7 days) after last dose of CS3005, up to 2 years

Eligibility
Key inclusion criteria
General

1. Be willing and able to provide written informed consent form for the trial.

2. Male or female between 18 to 75 years of age.

3. Ability to comply with requirements of the protocol, as assessed by the investigator.

4. Subjects who were histologically confirmed advanced solid tumor shall have progressed
disease and/or experienced intolerance from prior standard therapies, or for whom no
standard of care (SoC) therapies exist.

5. Subject must have at least one measurable lesion by CT or MRI; radiographic tumor
assessment should be performed within 28 days prior to the first dose of study
treatment.

6. ECOG performance status score of 0 or 1

7. Prior immunotherapy is allowed

8. Subjects who have previously received anti-tumor therapy will only be enrolled if the
toxicities from the previous treatment have returned to the baseline level or NCI
CTCAE v 5.0 grade =1.

9. Subject must have adequate organ function as indicated by the following laboratory
values, G-CSF or other relevant medical support within 14 days before the
administration of the investigational product

10. Subjects with active hepatitis B or active hepatitis C must receive antiviral
treatment and pass the HBV DNA titer test and HCV RNA test before being enrolled. The
subject should be willing to continue effective anti-viral treatment during the study.

11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
result. Either Female or male subjects must agree to use adequate contraceptive
measures.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has disease that is suitable for local treatment administered with curative intent

2. Has a history of a second malignancy active within the previous 3 years except for
locally curable cancers that have been apparently cured.

3. Patients with any condition that impairs their ability to take oral medication.

4. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

5. Subjects with active, known, or suspected autoimmune disease in the past 3 years prior
to the start of treatment.

6. History of active tuberculosis, both pulmonary and extrapulmonary.

7. Clinically Significant history of cardiac disease within 6 months prior to 1st dosing,
myocardial infarction within the previous year, or current cardiac ventricular
arrhythmias requiring medication.

8. Subjects with ascites, pleural effusion, pericardial effusion which cannot be reversed
by appropriate interventions.

9. Subjects with any active infections requiring systemic therapy within 2 weeks prior to
the initiation of the study treatment.

10. Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome.

11. History of organ transplant that requires the use of immunosuppressive treatment.

12. For post immunotherapy patients, with prior = Grade 3, serious, or life-threatening
immune-mediated reactions following prior anti-PD-(L)1 or other immune-oncology
therapies.

13. Subjects who have received systemic anti-tumor treatments 21 days prior to the
initiation of the study treatment.

14. Subjects who have received treatment with approved anti-tumor Chinese herbal medicine
or Chinese prepared.

15. Subjects with a condition requiring systemic treatment with either corticosteroids or
other immunosuppressive medications.

16. Has received treatment with non-selective adenosine antagonist or A2a receptor
antagonist.

17. Concurrent administration of strong inhibitors or inducers of CYP3A4 and CYP1A2 is not
permitted

For more information regarding trial participation, please contact at
[email protected]

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2021
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with
Advanced Solid Tumors
Trial website
https://clinicaltrials.gov/ct2/show/NCT04233060
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fei Li, PhD
Address 0 0
CStone Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04233060