- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475251
A Study of CS1003 in Subjects With Advanced Solid Tumors
February 17, 2022 updated by: CStone Pharmaceuticals
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
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- Scientia Clinical Research Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- ECOG performance status of 0 or 1.
- 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.
- Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
- Life expectancy ≥ 3 months.
- Subject must have adequate organ function.
- Use of effective contraception (males and females).
Exclusion Criteria:
- Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
- Subjects with active autoimmune diseases or history of autoimmune diseases.
- 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.
- 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.
- Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
- Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS1003.
- 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.
- Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS1003.
- Receipt of live vaccine within 28 days prior to the first dose of CS1003.
- History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
- History of HIV infection.
- Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.
- Subjects with active infection of tuberculosis.
- Subjects with signs or symptoms of any active infection requiring systemic therapy.
- History of organ transplantation.
- Unresolved toxicities from prior anti-cancer therapy.
- History of any irAE of Grade ≥ 3.
- History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
- History of alcoholism or drugs abuse.
- Subjects with major cardiovascular diseases.
- Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
CS1003 to be intravenously administered at the dose level determined during the dose escalation part
|
Experimental: CS1003 + regorafenib
|
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.
CS1003 to be intravenously administered at the dose level determined during the dose escalation part
Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events
Time Frame: From the day of first dose to 30 days after last dose of CS1003
|
From the day of first dose to 30 days after last dose of CS1003
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration-time curve (AUC)
Time Frame: From the day of first dose to 30 days after last dose of CS1003
|
From the day of first dose to 30 days after last dose of CS1003
|
Maximum plasma concentration (Cmax)
Time Frame: From the day of first dose to 30 days after last dose of CS1003
|
From the day of first dose to 30 days after last dose of CS1003
|
Time to reach maximum plasma concentration (Tmax)
Time Frame: From the day of first dose to 30 days after last dose of CS1003
|
From the day of first dose to 30 days after last dose of CS1003
|
Terminal elimination half-life (t1/2)
Time Frame: From the day of first dose to 30 days after last dose of CS1003
|
From the day of first dose to 30 days after last dose of CS1003
|
Disease assessment by CT/MRI scan
Time Frame: To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003
|
To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003
|
Anti-CS1003 antibody
Time Frame: From the day of first dose to 30 days after last dose of CS1003
|
From the day of first dose to 30 days after last dose of CS1003
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2018
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
May 31, 2021
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
March 22, 2018
First Posted (Actual)
March 23, 2018
Study Record Updates
Last Update Posted (Actual)
February 18, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CS1003-101
- ACTRN12618000382279 (Registry Identifier: The Australian New Zealand Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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