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Trial Title:
A Clinical Study to Evaluate the Safety, Tolerability,JS019 in Patients With Advanced Solid Tumors
NCT ID:
NCT05508373
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
JS019
Description:
Four dose levels are preset: 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. The subjects are
treated with JS019 by intravenous infusion, once every 3 weeks (Q3W). A treatment cycle
is 21 days, and the DLT observation period is 21 days after the first administration.
Arm group label:
Dose Escalation: dose level：0.3mg/kg
Arm group label:
Dose Escalation: dose level：1 mg/kg
Arm group label:
Dose Escalation: dose level：10 mg/kg
Arm group label:
Dose Escalation: dose level：3 mg/kg
Summary:
This is a phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics
and preliminary efficacy of JS019 as monotherapy in patients with advanced malignant
solid tumors The study includes JS019 monotherapy dose escalation, dose expansion stages
to investigate the safety, tolerability, pharmacokinetics and preliminary anti-tumor
efficacy of JS019 as monotherapy.
Detailed description:
Monotherapy Dose Escalation Stage:
In this stage, the safety and tolerability, PK characteristics, immunogenicity and
pharmacodynamics characteristics of JS019 are investigated. Four dosage groups are
preset: 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg. The drug is administered intravenously
every 3 weeks (Q3W). A treatment cycle is 21 days, with a DLT observation period of 21
days after the initial administration. The incremental dose and dosing interval may be
adjusted as necessary during the study based on safety, PK, and other results obtained
Monotherapy Dose Expansion Stage:
According to RP2D of JS019 single drug dose, 3-5 specific tumor types are selected for
indication expansion, and about 8-12 patients are enrolled for each indication. Tumor
types and additional cases could be selected according to the specific situation in the
trial process. It is planned to expand the cohort of lung cancer, pancreatic cancer,
sarcoma, hepatocellular carcinoma, cholangiocarcinoma and other solid tumors to explore
the efficacy and safety of JS019 single drug. The specific cohort will be adjusted
according to the results of previous studies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be able to understand and willing to sign the Informed Consent Form;
2. Male or female aged 18~75 years (included);
3. Patients with pathologically confirmed advanced malignant solid tumors
4. Failed or unsuitable for standard treatment;
5. Eastern Cooperative Oncology Group (ECOG) physical fitness score: 0~1;
6. Expected survival period ≥ 12 weeks;
7. At least one measurable lesion according to criteria RECIST v1.1 ;
Exclusion Criteria:
1. Patients with known hypersensitivity to the components of JS019;
2. Patients who have received the treatment with anti-CD39 antibodies or inhibitors;
3. Patients who participated in other clinical studies within 4 weeks prior to the
first administration of JS019, except patients are in the follow-up period of
observational (non-interventional) clinical study or interventional study;
4. Patients who have received major surgery within 4 weeks before the first dose or
expected to undergo major surgery during the study (as judged by the investigator)
or are in the recovery period from surgery;
5. Patients who have received anti-tumor therapy, such as chemotherapy, radiotherapy,
targeted therapy, immunotherapy, or biological therapy, within 4 weeks or 5
half-lives of the therapy (whichever is shorter) prior to the first dose of JS019.
Patients who have received traditional Chinese medicine or Chinese patent medicine
preparations with anti-tumor indications within 2 weeks before the first dose of
JS019. Can accept hormone therapy for non-tumor-related diseases (such as insulin
therapy for diabetes and hormone replacement therapy, etc.);
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong General Hospital
Address:
City:
Guangdong
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
Yilong Wu, bachelor's degree
Phone:
86020-83877855
Email:
syylwu@live.cn
Investigator:
Last name:
Huajun Chen, Doctor of Medicine
Email:
Principal Investigator
Start date:
March 29, 2022
Completion date:
August 10, 2024
Lead sponsor:
Agency:
Suzhou Kebo Ruijun Biotechnology Co., Ltd
Agency class:
Industry
Source:
Suzhou Kebo Ruijun Biotechnology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508373
