A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
NCT ID: NCT03809767
Last Updated: 2022-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
107 participants
INTERVENTIONAL
2018-10-29
2022-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CS1003 monoclonal antibody
CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks.
Interventions
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CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. ECOG performance status of 0 or 1.
4. 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.
5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
6. Life expectancy ≥ 3 months.
7. Subject must have adequate organ function.
8. Use of effective contraception (males and females).
Exclusion Criteria
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. 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.
4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
6. History of HIV infection.
7. Subjects with active Hepatitis B and C infection requiring therapy.
8. Subjects with active infection of tuberculosis.
9. History of organ transplantation.
10. Unresolved toxicities from prior anti-cancer therapy.
11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
12. Subjects with major cardiovascular diseases.
13. History of alcoholism or drugs abuse.
14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
18 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital Sichuan University
Chengdu, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Yunnan Cancer Hospital
Kunming, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Huashan Hospital Fudan University
Shanghai, , China
Shanghai East Hospital
Shanghai, , China
Shanghai pulmonary hospital
Shanghai, , China
Zhongshan Hospital
Shanghai, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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References
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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.
Gao 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.
Other Identifiers
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CS1003-102
Identifier Type: -
Identifier Source: org_study_id
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