A Phase 1 interventional study of JS019 in Advanced Solid Tumors, sponsored by Suzhou Kebo Ruijun Biotechnology Co., Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by Suzhou Kebo Ruijun Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 72 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Suzhou Kebo Ruijun Biotechnology Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Dose Escalation: 0.3mg/kg, IV infusion, every 3 weeks (q3w).
Biological: JS019
Dose Escalation: 1 mg/kg IV infusion, every 3 weeks (q3w).
Biological: JS019
Dose Escalation: 3 mg/kg IV infusion, every 3 weeks (q3w).
Biological: JS019
Dose Escalation: 10 mg/kg IV infusion, every 3 weeks (q3w).
Biological: JS019
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.
Safety Incidence of DLT severity of adverse events (AEs) and serious adverse events (SAEs)and tolerability
Incidence of DLT, incidence and severity of adverse events (AE) and severe adverse events (SAE), clinically significant abnormal laboratory changes and other tests
Time frame: 2 years
Maximum Tolerated Dose (MTD) or Optimal Biological Effect Dose (OBD) and Phase II study recommended dose (RP2D)
The safety, pharmacokinetic and preliminary efficacy data of the comprehensive dose escalation were determined. When MTD/OBD is determined, MTD/OBD is usually used as RP2D.
Time frame: 2 years
Pharmacokinetics (PK)
Drug concentrations in individual subjects at different time points after administration
Time frame: 2 years
Immunogenicity
Incidence of anti-drug antibodies (ADA), titer of ADA-positive samples.
Time frame: 2 years
Pharmacodynamics （PD）
CD39 receptor occupancy in peripheral blood.
Time frame: 2 years
Objective response rate (ORR)
The percentage of cases with remission (PR + CR) after treatment was assessable
Time frame: 2 years
Duration of response (DOR)
The time from the first assessment of CR or PR to the first assessment of PD or death due to any cause.
Time frame: 2 years
Disease control rate (DCR)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Time frame: 2 years
Time to response (TTR)
time from the start of treatment to progression of diease.
Time frame: 2 years
Progression-free survival (PFS)
PFS is defined as time from the start of treatment to progression of disease or death.
Time frame: 2 years
Overall survival (OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
Time frame: 2 years
Plan to share: Undecided
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Suzhou Kebo Ruijun Biotechnology Co., Ltd