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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/NCT03523819




Registration number
NCT03523819
Ethics application status
Date submitted
22/04/2018
Date registered
14/05/2018
Date last updated
16/12/2022

Titles & IDs
Public title
A Study of CS1002 in Subjects With Advanced Solid Tumors
Scientific title
A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
CS1002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CS1002
Treatment: Drugs - CS1003

Experimental: CS1002 - Participants will receive CS1002 intravenously at specified dose on specified days.

Experimental: CS1003 - Participants will receive CS1003 intravenously at fixed dose on specified days.


Treatment: Drugs: CS1002
Dose levels will be escalated following a modified 3+3 dose escalation scheme

Treatment: Drugs: CS1003
Fixed dose at 200mg in combination with CS1002 on a specified dose level
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 after last dose of CS1002

Eligibility
Key inclusion criteria
1. Subjects with histologically or cytologically confirmed advanced or metastatic solid
tumor(s) for which no effective standard therapy is available or tolerable.

2. ECOG performance status of 0 or 1.

3. Life expectancy =12 weeks.

4. Subjects must have adequate organ function

5. Use of effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known brain metastasis or other CNS metastasis that is either symptomatic or
untreated.

2. Subjects with active autoimmune diseases or history of autoimmune diseases.

3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other
immunosuppressive therapy within 14 days prior to the first dose of CS1002.

4. Has received prior therapy with an anti-CTLA-4 agent.

5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti
cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has
not recovered from adverse events due to prior therapy.

6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or
radioactive agents within specified time frame prior to the first dose of CS1002.

7. Receipt of live vaccine within 28 days prior to the first dose of CS1002

8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose
of CS1002.

9. History of interstitial lung disease or non-infectious pneumonitis except for those
induced by radiation therapies.

10. Known history of HIV.

11. Subjects with active Hepatitis B or C infection

12. Subjects with active tuberculosis infection.

13. Subjects with an active infection requiring systemic therapy.

14. History of organ transplantation.

15. History of alcoholism or drugs abuse.

16. History of severe hypersensitivity reactions to other mAbs.

17. Subjects with major cardiovascular diseases.

For more information regarding trial participation, please contact at
cstonera@cstonepharma.com

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2022
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Orange Health Service - Orange
Recruitment hospital [3] 0 0
St Vincent's hospital - Sydney
Recruitment hospital [4] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [5] 0 0
Ashford Cancer Centre Research - Adelaide
Recruitment hospital [6] 0 0
Cabrini Health - Malvern
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Boxhill Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
5037 - Adelaide
Recruitment postcode(s) [6] 0 0
3186 - Malvern
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate
the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03523819
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wanmei Wang
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