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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/NCT03475251




Registration number
NCT03475251
Ethics application status
Date submitted
14/03/2018
Date registered
23/03/2018
Date last updated
18/02/2022

Titles & IDs
Public title
A Study of CS1003 in Subjects With Advanced Solid Tumors
Scientific title
A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
ACTRN12618000382279
Secondary ID [2] 0 0
CS1003-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: CS1003 -

Experimental: CS1003 + regorafenib -


Other interventions: CS1003
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Other interventions: CS1003
CS1003 to be intravenously administered at the dose level determined during the dose escalation part

Treatment: Drugs: Regorafenib
Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle
Intervention code [1] 0 0
Other interventions
Intervention code [2] 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 CS1003
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [1] 0 0
From the day of first dose to 30 days after last dose of CS1003
Secondary outcome [2] 0 0
Maximum plasma concentration (Cmax)
Timepoint [2] 0 0
From the day of first dose to 30 days after last dose of CS1003
Secondary outcome [3] 0 0
Time to reach maximum plasma concentration (Tmax)
Timepoint [3] 0 0
From the day of first dose to 30 days after last dose of CS1003
Secondary outcome [4] 0 0
Terminal elimination half-life (t1/2)
Timepoint [4] 0 0
From the day of first dose to 30 days after last dose of CS1003
Secondary outcome [5] 0 0
Disease assessment by CT/MRI scan
Timepoint [5] 0 0
To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003
Secondary outcome [6] 0 0
Anti-CS1003 antibody
Timepoint [6] 0 0
From the day of first dose to 30 days after last dose of CS1003

Eligibility
Key inclusion criteria
1. Subjects must have histologically or cytologically confirmed advanced or metastatic
solid tumor and have progressed, are intolerant to, refuse to accept or do not have
access to standard therapy.

2. ECOG performance status of 0 or 1.

3. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects
must have at least one measurable lesion per RECIST Version 1.1 to be eligible for
Phase Ib.

4. Archived tumor tissue samples need to be collected, or subjects consent to undergo
pre-treatment biopsy if archived sample is not available.

5. Life expectancy = 3 months.

6. Subject must have adequate organ function.

7. Use of effective contraception (males and females).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.

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

3. Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent)
or other immunosuppression within 14 days prior to the first dose of CS1003.

4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase
Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical
carcinoma in situ who have undergone radical treatment.

5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1,
etc.

6. Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment
within 2 weeks prior to the first dose of CS1003.

7. Receipt of major surgical procedure or wide field of radiation within 28 days prior to
the first dose of CS1003, local radiotherapy within 14 days prior to the first dose of
CS1003, or radioactive agents within 56 days before the first dose of CS1003.

8. Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to
the first dose of CS1003.

9. Receipt of live vaccine within 28 days prior to the first dose of CS1003.

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

11. History of HIV infection.

12. Subjects with active Hepatitis B and C infection (HBV DNA = 1000 cps/mL or 200 IU/mL)
requiring therapy.

13. Subjects with active infection of tuberculosis.

14. Subjects with signs or symptoms of any active infection requiring systemic therapy.

15. History of organ transplantation.

16. Unresolved toxicities from prior anti-cancer therapy.

17. History of any irAE of Grade = 3.

18. History of uncontrolled allergic asthma and serious hypersensitive reaction to
monoclonal antibodies.

19. History of alcoholism or drugs abuse.

20. Subjects with major cardiovascular diseases.

21. Any condition that, in the opinion of the investigator or sponsor, would jeopardize
compliance.

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

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
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
9/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2021
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment
effect of a new drug known as CS1003 in patients with advanced tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03475251
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
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/NCT03475251