Clinical trial NCT03809767: A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lymphoma
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Willing to sign the informed consent.
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:

1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: from the day of first dose to 90 days after last dose of CS1003
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Shanghai pulmonary hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: