Advanced CancerPhase 1NCT03475251
A Study of CS1003 in Subjects With Advanced Solid Tumors
A Phase 1 study testing CS1003 and Regorafenib in people with Advanced Cancer, run by CStone Pharmaceuticals at 1 site in Australia.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- CS1003 and Regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteAustralia
- Study dates
- 9 May 2018to 31 May 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 must have histologically or cytologically confirmed advanced or metastatic solid tumor and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
- ECOG performance status of 0 or 1.
- Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
- Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
- Life expectancy ≥ 3 months.
- Subject must have adequate organ function.
- Use of effective contraception (males and females).
Who cannot join
- Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
- Subjects with active autoimmune diseases or history of autoimmune diseases.
- Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
- Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical carcinoma in situ who have undergone radical treatment.
- Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
- Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS1003.
Show all 22Show fewer
- Receipt of major surgical procedure or wide field of radiation within 28 days prior to the first dose of CS1003, local radiotherapy within 14 days prior to the first dose of CS1003, or radioactive agents within 56 days before the first dose of CS1003.
- Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS1003.
- Receipt of live vaccine within 28 days prior to the first dose of CS1003.
- History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
- History of HIV infection.
- Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.
- Subjects with active infection of tuberculosis.
- Subjects with signs or symptoms of any active infection requiring systemic therapy.
- History of organ transplantation.
- Unresolved toxicities from prior anti-cancer therapy.
- History of any irAE of Grade ≥ 3.
- History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
- History of alcoholism or drugs abuse.
- Subjects with major cardiovascular diseases.
- Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
- 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
Randwick, New South Wales, 2031
About this study
Official title: A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
- Conditions
- Advanced Cancer
- Being tested
- CS1003, Regorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1003Biological
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.
CS1003Biological
CS1003 to be intravenously administered at the dose level determined during the dose escalation part
RegorafenibDrug
Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| CS1003 | Experimental | Not described Receives: Biological: CS1003 |
| CS1003 + regorafenib | Experimental | Not described Receives: Biological: CS1003; Drug: Regorafenib |
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 after last dose of CS1003
Secondary outcomes (6)
Area under the plasma concentration-time curve (AUC)
Measured: From the day of first dose to 30 days after last dose of CS1003
Maximum plasma concentration (Cmax)
Measured: From the day of first dose to 30 days after last dose of CS1003
Time to reach maximum plasma concentration (Tmax)
Measured: From the day of first dose to 30 days after last dose of CS1003
Terminal elimination half-life (t1/2)
Measured: From the day of first dose to 30 days after last dose of CS1003
Disease assessment by CT/MRI scan
Measured: To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003
Anti-CS1003 antibody
Measured: From the day of first dose to 30 days after last dose of CS1003
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start9 May 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT03475251
- Sponsor's protocol ID
- CS1003-101
- Other IDs
- ACTRN12618000382279
- Status last verified
- Feb 2022
- First submitted
- 14 Mar 2018
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gong J, Guo Y, Zhang Y, Ba Y, Chen T, Li W, Zhou C, Wang M, Yang H, Zhou Y, Cai Q, Wang Z, Huang G, Zhang W, Su R, Cai Z, Yue Z, Dou J, Li P, Wu R, Tse AN, Shen L. A Phase 1a/1b Dose Escalation/Expansion Study of the Anti-PD-1 Monoclonal Antibody Nofazinlimab in Chinese Patients with Solid Tumors or Lymphoma. Target Oncol. 2024 Sep;19(5):723-733. doi: 10.1007/s11523-024-01091-8. Epub 2024 Sep 4.
PubMed 39231855Day D, Park JJ, Coward J, Markman B, Lemech C, Kuo JC, Prawira A, Brown MP, Bishnoi S, Kotasek D, Strother RM, Cosman R, Su R, Ma Y, Yue Z, Hu HH, Wu R, Li P, Tse AN. A first-in-human phase 1 study of nofazinlimab, an anti-PD-1 antibody, in advanced solid tumors and in combination with regorafenib in metastatic colorectal cancer. Br J Cancer. 2023 Nov;129(10):1608-1618. doi: 10.1038/s41416-023-02431-7. Epub 2023 Sep 20.
PubMed 37731023
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 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-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03475251
- Acronym / sponsor ID
- CS1003-101
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 23 Mar 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 study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS1003 | Experimental | Biological: CS1003 |
| CS1003 + regorafenib | Experimental | Biological: CS1003, Drug: Regorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
- ECOG performance status of 0 or 1.
- Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
- Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
- Life expectancy ≥ 3 months.
Key exclusion criteria (22 listed)
- Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
- Subjects with active autoimmune diseases or history of autoimmune diseases.
- Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
- Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical carcinoma in situ who have undergone radical treatment.
- Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
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 |
|---|---|---|
| CS1003In 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. | Biological | CS1003 |
| CS1003CS1003 to be intravenously administered at the dose level determined during the dose escalation part | Biological | CS1003 + regorafenib |
| RegorafenibRegorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle | Drug | CS1003 + regorafenib |
Primary outcome
Number of participants with adverse events
Time frame: From the day of first dose to 30 days after last dose of CS1003
6 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: From the day of first dose to 30 days after last dose of CS1003
Maximum plasma concentration (Cmax)
Time frame: From the day of first dose to 30 days after last dose of CS1003
Time to reach maximum plasma concentration (Tmax)
Time frame: From the day of first dose to 30 days after last dose of CS1003
Terminal elimination half-life (t1/2)
Time frame: From the day of first dose to 30 days after last dose of CS1003
Disease assessment by CT/MRI scan
Time frame: To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003
Anti-CS1003 antibody
Time frame: From the day of first dose to 30 days after last dose of CS1003
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 18 Feb 2022.
- Derived from this study: PubMed 39231855Gong J, Guo Y, Zhang Y, Ba Y, Chen T, Li W, Zhou C, Wang M, Yang H, Zhou Y, Cai Q, Wang Z, Huang G, Zhang W, Su R, Cai Z, Yue Z, Dou J, Li P, Wu R, Tse AN, Shen L. A Phase 1a/1b Dose Escalation/Expansion Study of the Anti-PD-1 Monoclonal Antibody Nofazinlimab in Chinese Patients with Solid Tumors or Lymphoma. Target Oncol. 2024 Sep;19(5):723-733. doi: 10.1007/s11523-024-01091-8. Epub 2024 Sep 4.
- Derived from this study: PubMed 37731023Day D, Park JJ, Coward J, Markman B, Lemech C, Kuo JC, Prawira A, Brown MP, Bishnoi S, Kotasek D, Strother RM, Cosman R, Su R, Ma Y, Yue Z, Hu HH, Wu R, Li P, Tse AN. A first-in-human phase 1 study of nofazinlimab, an anti-PD-1 antibody, in advanced solid tumors and in combination with regorafenib in metastatic colorectal cancer. Br J Cancer. 2023 Nov;129(10):1608-1618. doi: 10.1038/s41416-023-02431-7. Epub 2023 Sep 20.
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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 CS1003 and Regorafenib in people with Advanced Cancer, 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 7 inclusion and 22 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 18 Feb 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 after last dose of CS1003). 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 NCT03475251, which also lists 2 linked publications.
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 18 Feb 2022; AzTrials last refreshed its copy on 31 Oct 2026.