Clinical trial NCT03523819: A Study of CS1002 in Subjects with Advanced Solid Tumors
Official title: A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 As Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody CS1003 in Subjects with Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: Solid Tumors
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-05-14
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: From the day of first dose to 30 days after last dose of CS1002
Secondary outcomes:
Other outcomes:
Locations:
city: Albury
country: Australia
facility: Border Medical Oncology Research Unit
state: New South Wales
city: Orange
country: Australia
facility: Orange Health Service
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
state: New South Wales
city: Adelaide
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Malvern
country: Australia
facility: Cabrini Health
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Boxhill Hospital
state: Victoria
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: CStone Pharmaceuticals
name: Wanmei Wang
role: STUDY_DIRECTOR
References: