Solid TumorPhase 1NCT03809767
A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
A Phase 1 study testing CS1003 monoclonal antibody in people with Solid Tumor and Lymphoma, run by CStone Pharmaceuticals at 17 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 CS1003 in subjects with advanced solid tumors or lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- CS1003 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 17 sitesChina
- Study dates
- 29 Oct 2018to 13 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign the informed consent.
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma 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
- Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
- History of HIV infection.
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- Subjects with active Hepatitis B and C infection requiring therapy.
- Subjects with active infection of tuberculosis.
- History of organ transplantation.
- Unresolved toxicities from prior anti-cancer therapy.
- History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
- Subjects with major cardiovascular diseases.
- History of alcoholism or drugs abuse.
- Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Cancer Hospital
Beijing
Peking Union Medical College Hospital
Beijing
Peking University Third Hospital
Beijing
The First Hospital of Jilin University
Changchun
Hunan Cancer Hospital
Changsha
West China Hospital Sichuan University
Chengdu
Guangdong Provincial People's Hospital
Guangzhou
Zhejiang Cancer Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Yunnan Cancer Hospital
Kunming
The First Affiliated Hospital of Nanchang University
Nanchang
Huashan Hospital Fudan University
Shanghai
Shanghai East Hospital
Shanghai
Shanghai pulmonary hospital
Shanghai
Zhongshan Hospital
Shanghai
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Henan Cancer Hospital
Zhengzhou
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 or Lymphomas
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 CS1003 in subjects with advanced solid tumors or lymphoma.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- CS1003 monoclonal antibody
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1003 monoclonal antibodyDrug
CS1003 will be administered intravenously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CS1003 monoclonal antibody | Experimental | Not described Receives: Drug: CS1003 monoclonal antibody |
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 90 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 posted18 Jan 2019
- Study start29 Oct 2018
- Primary completion30 Aug 2021
- Study completion13 Jun 2022
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 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
- 107 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
- NCT03809767
- Sponsor's protocol ID
- CS1003-102
- Status last verified
- Nov 2022
- First submitted
- 15 Jan 2019
- Last updated
- 30 Nov 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 39231855Gao Y, Hu S, Li R, Jin S, Liu F, Liu X, Li Y, Yan Y, Liu W, Gong J, Yang S, Tu P, Shen L, Bai F, Wang Y. Hyperprogression of cutaneous T cell lymphoma after anti-PD-1 treatment. JCI Insight. 2023 Feb 22;8(4):e164793. doi: 10.1172/jci.insight.164793.
PubMed 36649072
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 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 or Lymphomas
- ClinicalTrials.gov ID
- NCT03809767
- Acronym / sponsor ID
- CS1003-102
- Conditions
- Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 18 Jan 2019 (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 CS1003 in subjects with advanced solid tumors or lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS1003 monoclonal antibody | Experimental | Drug: CS1003 monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to sign the informed consent.
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma 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.
Key exclusion criteria (14 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
- 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 |
|---|---|---|
| CS1003 monoclonal antibodyCS1003 will be administered intravenously every 3 weeks. | Drug | CS1003 monoclonal antibody |
Primary outcome
Number of participants with adverse events
Time frame: from the day of first dose to 90 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 30 Nov 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 36649072Gao Y, Hu S, Li R, Jin S, Liu F, Liu X, Li Y, Yan Y, Liu W, Gong J, Yang S, Tu P, Shen L, Bai F, Wang Y. Hyperprogression of cutaneous T cell lymphoma after anti-PD-1 treatment. JCI Insight. 2023 Feb 22;8(4):e164793. doi: 10.1172/jci.insight.164793.
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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.
17 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 CS1003 monoclonal antibody in people with Solid Tumor and Lymphoma, run by CStone Pharmaceuticals at 17 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 8 inclusion and 14 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 30 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 17 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?
Number of participants with adverse events (time frame: from the day of first dose to 90 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 NCT03809767, 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 30 Nov 2022.