Solid Tumor, Adult
Conditions
Keywords
Solid Tumors
Brief summary
This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.
Interventions
Sponsors
CStone Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Randomized for Part 3 of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. 2. ECOG performance status of 0 or 1. 3. Life expectancy ≥12 weeks. 4. Subjects must have adequate organ function 5. Use of effective contraception
Exclusion criteria
1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. 2. Subjects with active autoimmune diseases or history of autoimmune diseases. 3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002. 4. Has received prior therapy with an anti-CTLA-4 agent. 5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy. 6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002. 7. Receipt of live vaccine within 28 days prior to the first dose of CS1002 8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002. 9. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies. 10. Known history of HIV. 11. Subjects with active Hepatitis B or C infection 12. Subjects with active tuberculosis infection. 13. Subjects with an active infection requiring systemic therapy. 14. History of organ transplantation. 15. History of alcoholism or drugs abuse. 16. History of severe hypersensitivity reactions to other mAbs. 17. Subjects with major cardiovascular diseases. For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | From the day of first dose to 30 days after last dose of CS1002 |
Countries
Australia, Hong Kong
Outcome results
None listed