Solid Tumor, AdultPhase 1NCT03523819
A Study of CS1002 in Subjects with Advanced Solid Tumors
A Phase 1 study testing CS1002 and CS1003 in people with Solid Tumor, Adult, run by CStone Pharmaceuticals at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- CS1002 and CS1003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 26 Apr 2018to 18 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Subjects must have adequate organ function
- Use of effective contraception
Who cannot join
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Subjects with active autoimmune diseases or history of autoimmune diseases.
- Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
- Has received prior therapy with an anti-CTLA-4 agent.
- 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.
- 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.
Show all 18Show fewer
- Receipt of live vaccine within 28 days prior to the first dose of CS1002
- Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
- History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
- Known history of HIV.
- Subjects with active Hepatitis B or C infection
- Subjects with active tuberculosis infection.
- Subjects with an active infection requiring systemic therapy.
- History of organ transplantation.
- History of alcoholism or drugs abuse.
- History of severe hypersensitivity reactions to other mAbs.
- Subjects with major cardiovascular diseases.
- For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Australia8 sites
Ashford Cancer Centre Research
Adelaide, South Australia, 5037
Border Medical Oncology Research Unit
Albury, New South Wales, 2640
Cabrini Health
Malvern, Victoria, 3186
Alfred Hospital
Melbourne, Victoria, 3004
Boxhill Hospital
Melbourne, Victoria, 3128
Orange Health Service
Orange, New South Wales, 2800
St Vincent's hospital
Sydney, New South Wales, 2010
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
Official 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
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- CS1002, CS1003
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1002Drug
Also called anti-CTLA 4
Dose levels will be escalated following a modified 3+3 dose escalation scheme
CS1003Drug
Also called anti-PD1
Fixed dose at 200mg in combination with CS1002 on a specified dose level
| Study group | Role | What they receive |
|---|---|---|
| CS1002 | Experimental | Participants will receive CS1002 intravenously at specified dose on specified days. Receives: Drug: CS1002; Drug: CS1003 |
| CS1003 | Experimental | Participants will receive CS1003 intravenously at fixed dose on specified days. Receives: Drug: CS1002; Drug: CS1003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: From the day of first dose to 30 days after last dose of CS1002
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start26 Apr 2018
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wanmei Wang, Study director, CStone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523819
- Sponsor's protocol ID
- CS1002-101
- Status last verified
- Dec 2022
- First submitted
- 22 Apr 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03523819
- Acronym / sponsor ID
- CS1002-101
- Conditions
- Solid Tumor, Adult
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS1002 | Experimental | Drug: CS1002, Drug: CS1003Participants will receive CS1002 intravenously at specified dose on specified days. |
| CS1003 | Experimental | Drug: CS1002, Drug: CS1003Participants will receive CS1003 intravenously at fixed dose on specified days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Subjects must have adequate organ function
- Use of effective contraception
Key exclusion criteria (18 listed)
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Subjects with active autoimmune diseases or history of autoimmune diseases.
- Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
- Has received prior therapy with an anti-CTLA-4 agent.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS1002Also: anti-CTLA 4Dose levels will be escalated following a modified 3+3 dose escalation scheme | Drug | CS1002, CS1003 |
| CS1003Also: anti-PD1Fixed dose at 200mg in combination with CS1002 on a specified dose level | Drug | CS1002, CS1003 |
Primary outcome
Number of participants with adverse events
Time frame: From the day of first dose to 30 days after last dose of CS1002
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanmei Wang study director
CStone Pharmaceuticals
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS1002 and CS1003 in people with Solid Tumor, Adult, run by CStone Pharmaceuticals at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: From the day of first dose to 30 days after last dose of CS1002). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.