A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
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
1 other identifier
interventional
107
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2018
Typical duration for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2018
CompletedFirst Submitted
Initial submission to the registry
January 15, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2022
CompletedNovember 30, 2022
November 1, 2022
2.8 years
January 15, 2019
November 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
from the day of first dose to 90 days after last dose of CS1003
Study Arms (1)
CS1003 monoclonal antibody
EXPERIMENTALInterventions
CS1003 will be administered intravenously every 3 weeks.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Related Publications (2)
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.
PMID: 39231855DERIVEDGao 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.
PMID: 36649072DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2019
First Posted
January 18, 2019
Study Start
October 29, 2018
Primary Completion
August 30, 2021
Study Completion
June 13, 2022
Last Updated
November 30, 2022
Record last verified: 2022-11