Advanced Solid TumorPhase 1NCT04233060
A Study of CS3005 in Advanced Solid Tumors
A Phase 1 study testing CS3005 in people with Advanced Solid Tumor, run by CStone Pharmaceuticals at 1 site in Australia.
Trial summary
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CS3005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jan 2020to 17 Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Has disease that is suitable for local treatment administered with curative intent
- Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- Patients with any condition that impairs their ability to take oral medication.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects with active, known, or suspected autoimmune disease in the past 3 years prior to the start of treatment.
- History of active tuberculosis, both pulmonary and extrapulmonary.
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- Clinically Significant history of cardiac disease within 6 months prior to 1st dosing, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication.
- Subjects with ascites, pleural effusion, pericardial effusion which cannot be reversed by appropriate interventions.
- Subjects with any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment.
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- History of organ transplant that requires the use of immunosuppressive treatment.
- For post immunotherapy patients, with prior ≥ Grade 3, serious, or life-threatening immune-mediated reactions following prior anti-PD-(L)1 or other immune-oncology therapies.
- Subjects who have received systemic anti-tumor treatments 21 days prior to the initiation of the study treatment.
- Subjects who have received treatment with approved anti-tumor Chinese herbal medicine or Chinese prepared.
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
- Has received treatment with non-selective adenosine antagonist or A2a receptor antagonist.
- Concurrent administration of strong inhibitors or inducers of CYP3A4 and CYP1A2 is not permitted
- For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Sydney, New South Wales, 2031
About this study
Official title: A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects With Advanced Solid Tumors
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- CS3005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS3005Drug
CS3005 will be orally administrated twice daily (BID) until PD, unacceptable toxicity, withdrawal of informed consent, or until maximum treatment duration per protocol (2 years)
| Study group | Role | What they receive |
|---|---|---|
| CS3005 | Experimental | Not described Receives: Drug: CS3005 |
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 (±7 days) after last dose of CS3005, 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 posted18 Jan 2020
- Study start10 Jan 2020
- Primary completion31 Jan 2021
- Study completion17 Feb 2021
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
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Li, PhD, Study director, CStone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233060
- Sponsor's protocol ID
- CS3005-101
- Status last verified
- Apr 2022
- First submitted
- 15 Jan 2020
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04233060
- Acronym / sponsor ID
- CS3005-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 18 Jan 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.
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 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 |
|---|---|---|
| CS3005 | Experimental | Drug: CS3005 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Has disease that is suitable for local treatment administered with curative intent
- Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- Patients with any condition that impairs their ability to take oral medication.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects with active, known, or suspected autoimmune disease in the past 3 years prior to the start of treatment.
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 |
|---|---|---|
| CS3005CS3005 will be orally administrated twice daily (BID) until PD, unacceptable toxicity, withdrawal of informed consent, or until maximum treatment duration per protocol (2 years) | Drug | CS3005 |
Primary outcome
Number of participants with adverse events
Time frame: From the day of first dose to 30 days (±7 days) after last dose of CS3005, 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 27 Apr 2022.
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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.
Fei Li, PhD study director
CStone Pharmaceuticals
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 CS3005 in people with Advanced Solid Tumor, run by CStone Pharmaceuticals at 1 site in Australia.
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 0 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 27 Apr 2022. 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 Australia. 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 (±7 days) after last dose of CS3005, 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 27 Apr 2022.