Advanced CancerPhase 1NCT03312842
A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors
A Phase 1 study testing CS1001 in people with Advanced Cancer, run by CStone Pharmaceuticals at 2 sites in China.
Trial summary
This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion 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 to 75 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- CS1001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 2 sitesChina
- Study dates
- 19 Oct 2017to 16 Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- 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 six months 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 immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Known history of HIV infection.
- Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- Known history of alcoholism or drugs abuse.
- For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
- Conditions
- Advanced Cancer
- 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, patients will be assigned to different groups based on their tumor type.
| Study group | Role | What they receive |
|---|---|---|
| CS1001 | Experimental | Not described Receives: Drug: CS1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of CS1001
Measured: From first dose to 30 days after last dose of CS1001, up to 2 years
To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001
Measured: From first dose to 30 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 posted18 Oct 2017
- Study start19 Oct 2017
- Primary completion16 Aug 2021
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies 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
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312842
- Sponsor's protocol ID
- CS1001-101
- Status last verified
- Feb 2022
- First submitted
- 13 Oct 2017
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gong J, Cao J, Zhang Q, Xu N, Zhao Y, Xing B, Miao Z, Wu Y, Pan H, Gao Q, Li X, Liu B, Li W, Pei Z, Xia H, Qi Q, Dai H, Shi Q, Yang J, Li J, Shen L. Safety, antitumor activity and biomarkers of sugemalimab in Chinese patients with advanced solid tumors or lymphomas: results from the first-in-human phase 1 trial. Cancer Immunol Immunother. 2022 Aug;71(8):1897-1908. doi: 10.1007/s00262-021-03102-3. Epub 2022 Jan 5.
PubMed 34984540
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03312842
- Acronym / sponsor ID
- CS1001-101
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 18 Oct 2017 (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 Ia/Ib, open-label, multiple-dose, dose-escalation and expansion 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 | Experimental | Drug: CS1001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- 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 (8 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 immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Known history of HIV infection.
- Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
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, patients will be assigned to different groups based on their tumor type. | Drug | CS1001 |
Primary outcome
To evaluate the safety and tolerability of CS1001
Time frame: From first dose to 30 days after last dose of CS1001, up to 2 years
To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001
Time frame: From first dose to 30 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 26 May 2022.
- Derived from this study: PubMed 34984540Gong J, Cao J, Zhang Q, Xu N, Zhao Y, Xing B, Miao Z, Wu Y, Pan H, Gao Q, Li X, Liu B, Li W, Pei Z, Xia H, Qi Q, Dai H, Shi Q, Yang J, Li J, Shen L. Safety, antitumor activity and biomarkers of sugemalimab in Chinese patients with advanced solid tumors or lymphomas: results from the first-in-human phase 1 trial. Cancer Immunol Immunother. 2022 Aug;71(8):1897-1908. doi: 10.1007/s00262-021-03102-3. Epub 2022 Jan 5.
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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.
Lin Shen, MD principal investigator
Peking University Cancer Hospital & Institute
2 sites 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 Cancer, run by CStone Pharmaceuticals at 2 sites 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 6 inclusion and 8 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 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To evaluate the safety and tolerability of CS1001 (time frame: From first dose to 30 days after last dose of CS1001, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312842, which also lists 1 linked publication.
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 26 May 2022.