Advanced Solid TumorPhase 1NCT04472858
A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors
A Phase 1 study testing Donafenib and CS1001 in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients 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?
- Donafenib and CS1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2020to Dec 2023
- 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
- Fully understand this study and voluntarily sign ICF;
- 18 to 75 years old (including 18 and 75 years old), male or female;
- Subjects with advanced solid tumors, including:
- Phase I study:
- subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
Who cannot join
- Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included;
- Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter;
- Human immunodeficiency virus (HIV) antibody positive;
- Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;
- Lactating women. If they are willing to stop breastfeeding, they can also be included in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eastern Hospital
Shanghai, Shanghai Municipality
Yan Guo, MD, 13501678472, pattrickguo@gmail.com
About this study
Official title: A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.
Read the detailed description
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
- Conditions
- Advanced Solid Tumor
- Being tested
- Donafenib, CS1001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafenibDrug
dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
CS1001Drug
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Cholangiocarcinoma | Experimental | Cholangiocarcinoma Receives: Drug: Donafenib; Drug: CS1001 |
| Squamous cell carcinoma of the head and neck | Experimental | Squamous cell carcinoma of the head and neck（HNSCC） Receives: Drug: Donafenib; Drug: CS1001 |
| Endometrial cancer | Experimental | Endometrial cancer Receives: Drug: Donafenib; 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 the day of first dose to 21 days after last dose
To determine the dose limiting toxicity (DLT)
Measured: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the maximum tolerated dose(MTD)
Measured: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the recommended dose of phase II
Measured: In the dose escalation part, from the day of first dose to 21 days after last dose
Objective response rate as determined by the Invertigator using RECIST V1.1
Measured: In the dose escalation part, from the day of first dose to 21 days after last dose
Secondary outcomes (5)
Anti-CS1001 antibody
Measured: From the day of first dose to 21 days after last dose
Objective response rate (ORR)
Measured: From the day of first dose to 21 days after last dose
Overall survival(OS)
Measured: From the day of first dose to 21 days after last dose
Progression free survival(PFS)
Measured: From the day of first dose to 21 days after last dose
Duration of remission (DOR)
Measured: From the day of first dose to 21 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start15 Oct 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CStone Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ye Guo, MD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472858
- Sponsor's protocol ID
- CS1001/Donafenib-101
- Status last verified
- Nov 2022
- First submitted
- 8 Jul 2020
- Last updated
- 29 Nov 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04472858
- Acronym / sponsor ID
- CS1001/Donafenib-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- CStone Pharmaceuticals
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Jul 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 study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.
Detailed description
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholangiocarcinoma | Experimental | Drug: Donafenib, Drug: CS1001Cholangiocarcinoma |
| Squamous cell carcinoma of the head and neck | Experimental | Drug: Donafenib, Drug: CS1001Squamous cell carcinoma of the head and neck（HNSCC） |
| Endometrial cancer | Experimental | Drug: Donafenib, Drug: CS1001Endometrial cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand this study and voluntarily sign ICF;
- 18 to 75 years old (including 18 and 75 years old), male or female;
- Subjects with advanced solid tumors, including:
- subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
Key exclusion criteria (6 listed)
- Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included;
- Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter;
- Human immunodeficiency virus (HIV) antibody positive;
- Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;
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 |
|---|---|---|
| Donafenibdose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study. | Drug | Cholangiocarcinoma, Endometrial cancer, Squamous cell carcinoma of the head and neck |
| CS1001CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days | Drug | Cholangiocarcinoma, Endometrial cancer, Squamous cell carcinoma of the head and neck |
Primary outcome
Number of participants with adverse events
Time frame: From the day of first dose to 21 days after last dose
To determine the dose limiting toxicity (DLT)
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the maximum tolerated dose(MTD)
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the recommended dose of phase II
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
Objective response rate as determined by the Invertigator using RECIST V1.1
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
5 secondary outcomes
Anti-CS1001 antibody
Time frame: From the day of first dose to 21 days after last dose
Objective response rate (ORR)
Time frame: From the day of first dose to 21 days after last dose
Overall survival(OS)
Time frame: From the day of first dose to 21 days after last dose
Progression free survival(PFS)
Time frame: From the day of first dose to 21 days after last dose
Duration of remission (DOR)
Time frame: From the day of first dose to 21 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 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.
Ye Guo, MD principal investigator
Shanghai East Hospital
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 Donafenib and CS1001 in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye Guo, MD (13501678472, pattrickguo@gmail.com), or a site near the patient. 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 21 days after last dose). The study lists 5 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 29 Nov 2022.