Status unknownNCT05374226Updated May 16, 2022

A Phase 1 Study to Evaluate JS019 in Advanced Solid Tumors or Lymphomas

A Phase 1 interventional study of JS019 in Advanced Solid Tumors or Lymphomas, 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 2022-05-16.

Sponsored by Suzhou Kebo Ruijun Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 172
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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/lymphomas.

The study includes JS019 monotherapy dose escalation, dose expansion and indication expansion stages to investigate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of JS019 as monotherapy.

Read the detailed description

Monotherapy Dose Escalation Stage:

In this stage, the safety and tolerability, PK characteristics, immunogenicity and PD of JS019 are investigated. 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. During the study, necessary adjustments may be made to the escalating dose and dosing interval based on the safety, PK and other results obtained.

Monotherapy Dose Expansion Stage:

SMC will select 1\~2 dose levels (dose levels in the monotherapy dose escalation stage or intermediate dose levels) of JS019 as monotherapy. Each dose level includes 6\~9 subjects with advanced malignancies to further evaluate the safety, pharmacokinetics, immunogenicity, pharmacodynamics and efficacy of JS019 as monotherapy, and determine the RP2D of JS019 as monotherapy.

Monotherapy Indication Expansion Stage Based on the determined RP2D of JS019 as monotherapy, 2-4 specific malignancies are selected for indication expansion; about 20-30 patients are included for each indication. It is planned to include expansion cohorts to explore the efficacy and safety of JS019 as monotherapy. The actual cohorts included may be adjusted based on the results of the previous studies.

Conditions studied

Advanced Solid Tumors or Lymphomas

Browse trials for

Lymphoma 5,578

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 172 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Suzhou Kebo Ruijun Biotechnology Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Be able to understand and willing to sign the Informed Consent Form;
Male or female aged 18\~75 years (included);
Patients with pathologically confirmed advanced malignant solid tumors or lymphomas;
Failed or unsuitable for standard treatment, received at least one line of systemic treatment;
Eastern Cooperative Oncology Group (ECOG) physical fitness score: 0\~1;
Expected survival period ≥ 12 weeks;
At least one measurable lesion according to criteria RECIST v1.1 or Lugano 2014;

Exclusion criteria

Exclusion Criteria:

Patients with known hypersensitivity to the components of JS019;
Patients who have received the treatment with anti-CD39 antibodies or inhibitors;
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;
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;
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.);
Patients who have discontinued immunotherapy due to immune-related AEs.
Patients who have used immunosuppressive drugs within 4 weeks prior to the first dose of JS019, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids ≤10 mg/day prednisone or equivalent.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 172 participants (estimated)

Study arms

Experimental
JS019 0.3 mg/kg
repeat dose every 21 days up
Biological: JS019
Experimental
JS019 1 mg/kg
repeat dose every 21 days up
Biological: JS019
Experimental
JS019 3 mg/kg
repeat dose every 21 days up
Biological: JS019
Experimental
JS019 10 mg/kg
repeat dose every 21 days up
Biological: JS019

Interventions

BiologicalJS019
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.

What researchers measure

Primary outcomes

Safety and tolerability
Incidence of DLT, incidence and severity of adverse events (AEs) and serious adverse events (SAEs), clinically significant abnormal changes in laboratory tests and other tests
Time frame: 2 years
Maximum tolerated dose (MTD, if possible) and the recommended phase 2 dose (RP2D)
Maximum tolerated dose (MTD) : The highest dose at which \<1/3 patients experience DLT events. Phase II recommended dose: safety, pharmacokinetics, and preliminary efficacy data of dose escalation will be integrated. When the Maximum tolerated dose(MTD) is determined, the Maximum tolerated dose(MTD) is usually used as the Phase II recommended dose(RP2D), or the dose lower than the Maximum tolerated dose(MTD) is selected as the Phase II recommended dose(RP2D) based on the comprehensive data.
Time frame: 2 years

Secondary outcomes

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

Other outcomes

Biomarkers
The expression levels of CD39, P2X7, PD-L1 and CD8+ in tumor tissue, and the correlation between their expression levels and efficacy.
Time frame: 2 years

Study locations

1 of 1 sites recruiting

Beijing Cancer Hospital
Beijing, Beijing 100142, China
- lin shen, Doctor of medicine · Contact · linshenpku@163.com · 8610-88196561
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05374226
Lead sponsor: Suzhou Kebo Ruijun Biotechnology Co., Ltd
Responsible party: Sponsor
First posted: May 16, 2022
Start date: Mar 31, 2022
Primary completion: Dec 11, 2023 (estimated)
Completion: Mar 7, 2024 (estimated)
Last update: May 16, 2022

Study contacts

lin shen, Doctor of medicine

Contact

linshenpku@163.com

8610-88196561

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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