Advanced Solid TumorsPhase 1NCT03744403
A Study of CS1001 in Subjects with Advanced Solid Tumors
A Phase 1 study testing CS1001 in people with Advanced Solid Tumors, run by CStone Pharmaceuticals at 1 site in United States.
Trial summary
This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CS1001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 21 Jul 2021
- 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 metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
- ECOG performance status of 0 or 1.
- Subjects must have at least one measurable lesion.
- Patients with life expectancy ≥ 3 months.
- Subject must have adequate organ function.
- 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 study drug administration.
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 should be excluded.
- Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-4.
- Known history of HIV infection.
- Subjects with active Hepatitis B or C infection.
- Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
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- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- Known history of alcoholism or drugs abuse.
- Subjects who received organ transplantation.
- Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
- Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.
- For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects with Advanced Solid Tumors
This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- CS1001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1001Drug
In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose-expansion part, both dose levels will be expanded.
| Study group | Role | What they receive |
|---|---|---|
| CS1001 monoclonal antibody | Experimental | Not described Receives: Drug: CS1001 |
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 first dose to 90 days after last dose of CS1001, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start4 Dec 2018
- Primary completion31 Oct 2020
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03744403
- Sponsor's protocol ID
- CS1001-102
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects with Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03744403
- Acronym / sponsor ID
- CS1001-102
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 16 Nov 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 phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS1001 monoclonal antibody | Experimental | Drug: CS1001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
- ECOG performance status of 0 or 1.
- Subjects must have at least one measurable lesion.
- Patients with life expectancy ≥ 3 months.
- Subject must have adequate organ function.
Key exclusion criteria (12 listed)
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-4.
- Known history of HIV infection.
- Subjects with active Hepatitis B or C infection.
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 |
|---|---|---|
| CS1001In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose-expansion part, both dose levels will be expanded. | Drug | CS1001 monoclonal antibody |
Primary outcome
Number of participants with adverse events
Time frame: From first dose to 90 days after last dose of CS1001, up to 2 years
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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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 CS1001 in people with Advanced Solid Tumors, run by CStone Pharmaceuticals at 1 site in United States.
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 6 inclusion and 12 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 1 site in United States. 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 first dose to 90 days after last dose of CS1001, up to 2 years). 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.