Advanced Solid TumorPhase 1NCT04338724
A Phase I Study of CS1002 in Subjects With Advanced Solid Tumors
A Phase 1 study testing CS1002 in people with Advanced Solid Tumor, run by CStone Pharmaceuticals at 1 site in China.
Trial summary
This is an open label, dose escalation phase I study to evaluate the clinical safety, tolerability in subjects with advanced solid tumors, and to establish the Maximum Tolerated Dose (MTD#, if any). This study is composed of two dose level: 1 and 3 mg/kg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CS1002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2019to 21 Sep 2020
- 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
- Willing and able to provide written informed consent for the study.
- Being ≥18 years of age on the day of signing informed consent.
- Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with evaluable but non-measurable lesion are allowed to participate in the study.
- Life expectancy ≥12 weeks.
- Subject must have adequate organ function as indicated by laboratory values
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of investigational product.
Who cannot join
- The subject must be excluded from participating in the study if the subject:
- Known brain metastasis, primary central nervous system (CNS) or another CNS metastasis that is either symptomatic or untreated. Central nervous system metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by imaging for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
- Subjects with active autoimmune diseases or a history of autoimmune diseases should be excluded; these include but are not limited to subjects with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue diseases, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, hepatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, or antiphospholipid syndrome.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (eg, >10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the Cycle 1 Day 1. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Has received prior therapy with an anti-CTLA-4 agent.
- Has had prior chemotherapy, targeted therapy, or any other agents used as a systemic treatment for cancer, within 21 days of Cycle 1 Day 1
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- Known history of human immunodeficiency virus (HIV) infection.
- Active tuberculosis infection.
- Subjects with a known history of alcoholism or drugs abuse.
- Subjects with the major cardiovascular condition (eg, congestive heart failure, unstable angina pectoris, atrial fibrillation, arrhythmia.): subjects who had experienced such conditions such as acute myocardial infarction, unstable angina pectoris, apoplexia, or transient ischemic attack within 6 months prior to Cycle 1 Day 1; subjects with congestive heart failure of New York Heart Association Grade ≥2.
- Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Women with pregnancy or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 in Subjects With Advanced Solid Tumors
This is an open label, dose escalation phase I study to evaluate the clinical safety, tolerability in subjects with advanced solid tumors, and to establish the Maximum Tolerated Dose (MTD#, if any). This study is composed of two dose level: 1 and 3 mg/kg.
- Conditions
- Advanced Solid Tumor
- Being tested
- CS1002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1002Drug
The dose levels will be escalated following a modified 3+3 dose escalation scheme.
| Study group | Role | What they receive |
|---|---|---|
| CS1002 | Experimental | Not described Receives: Drug: CS1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Number of participants with adverse events
Measured: From the day of first dose to 21 days after last dose
area under the curve
(AUC)0-21d
Measured: From the time of infusion to 21 days after first dose and forth dose
maximum observed serum concentration (Cmax)
Measured: From the time of infusion to 21 days after first dose and forth dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start27 Dec 2019
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338724
- Sponsor's protocol ID
- CS1002-102
- Status last verified
- Feb 2021
- First submitted
- 31 Mar 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04338724
- Acronym / sponsor ID
- CS1002-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 8 Apr 2020 (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 an open label, dose escalation phase I study to evaluate the clinical safety, tolerability in subjects with advanced solid tumors, and to establish the Maximum Tolerated Dose (MTD#, if any). This study is composed of two dose level: 1 and 3 mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS1002 | Experimental | Drug: CS1002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide written informed consent for the study.
- Being ≥18 years of age on the day of signing informed consent.
- Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with evaluable but non-measurable lesion are allowed to participate in the study.
Key exclusion criteria (13 listed)
- Known brain metastasis, primary central nervous system (CNS) or another CNS metastasis that is either symptomatic or untreated. Central nervous system metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by imaging for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
- Subjects with active autoimmune diseases or a history of autoimmune diseases should be excluded; these include but are not limited to subjects with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue diseases, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, hepatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, or antiphospholipid syndrome.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (eg, >10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the Cycle 1 Day 1. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Has received prior therapy with an anti-CTLA-4 agent.
- Has had prior chemotherapy, targeted therapy, or any other agents used as a systemic treatment for cancer, within 21 days of Cycle 1 Day 1
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 |
|---|---|---|
| CS1002The dose levels will be escalated following a modified 3+3 dose escalation scheme. | Drug | CS1002 |
Primary outcome
safety and tolerability
Time frame: From the day of first dose to 21 days after last dose
Number of participants with adverse events
area under the curve
Time frame: From the time of infusion to 21 days after first dose and forth dose
(AUC)0-21d
maximum observed serum concentration (Cmax)
Time frame: From the time of infusion to 21 days after first dose and forth dose
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 21 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS1002 in people with Advanced Solid Tumor, run by CStone Pharmaceuticals at 1 site in China.
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 8 inclusion and 13 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
safety and tolerability (time frame: From the day of first dose to 21 days after last dose). The study lists 3 primary outcomes in all. 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 21 Feb 2021.