Status:
COMPLETED
A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
Lead Sponsor:
CStone Pharmaceuticals
Conditions:
Solid Tumor
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
October 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03809767
Start Date
October 29 2018
End Date
June 13 2022
Last Update
November 30 2022
Active Locations (17)
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1
Beijing Cancer Hospital
Beijing, China
2
Peking Union Medical College Hospital
Beijing, China
3
Peking University Third Hospital
Beijing, China
4
The First Hospital of Jilin University
Changchun, China