Advanced Solid Tumors or LymphomasPhase 1NCT05374226
A Phase 1 Study to Evaluate JS019 in Advanced Solid Tumors or Lymphomas
A Phase 1 study testing JS019 in people with Advanced Solid Tumors or Lymphomas, run by Suzhou Kebo Ruijun Biotechnology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors or Lymphomas
- What is being tested?
- JS019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2022to 7 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
lin shen, Doctor of medicine, 8610-88196561, linshenpku@163.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Fully Human Anti-CD39 Monoclonal Antibody JS019 in Patients With Advanced Solid Tumors or Lymphomas
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
- Advanced Solid Tumors or Lymphomas
- Being tested
- JS019
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS019Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| JS019 0.3 mg/kg | Experimental | repeat dose every 21 days up Receives: Biological: JS019 |
| JS019 1 mg/kg | Experimental | repeat dose every 21 days up Receives: Biological: JS019 |
| JS019 3 mg/kg | Experimental | repeat dose every 21 days up Receives: Biological: JS019 |
| JS019 10 mg/kg | Experimental | repeat dose every 21 days up Receives: Biological: JS019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Secondary outcomes (9)
Pharmacokinetics (PK)
Drug concentrations in individual subjects at different time points after administration
Measured: 2 years
Immunogenicity
Incidence of anti-drug antibodies (ADA), titer of ADA-positive samples.
Measured: 2 years
Pharmacodynamics （PD）
CD39 receptor occupancy in peripheral blood.
Measured: 2 years
Objective response rate (ORR)
The percentage of cases with remission (PR + CR) after treatment was assessable
Measured: 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.
Measured: 2 years
Disease control rate (DCR)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Measured: 2 years
Time to response (TTR)
time from the start of treatment to progression of diease.
Measured: 2 years
Progression-free survival (PFS)
PFS is defined as time from the start of treatment to progression of disease or death.
Measured: 2 years
Overall survival (OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start31 Mar 2022
- Primary completion11 Dec 2023 (estimated)
- Study completion7 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors or LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Kebo Ruijun Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374226
- Sponsor's protocol ID
- JS019-001-I
- Status last verified
- Apr 2022
- First submitted
- 5 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Fully Human Anti-CD39 Monoclonal Antibody JS019 in Patients With Advanced Solid Tumors or Lymphomas
- ClinicalTrials.gov ID
- NCT05374226
- Acronym / sponsor ID
- JS019-001-I
- Conditions
- Advanced Solid Tumors or Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Suzhou Kebo Ruijun Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 11 Dec 2023 (estimated)
- Study completion
- 7 Mar 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JS019 0.3 mg/kg | Experimental | Biological: JS019repeat dose every 21 days up |
| JS019 1 mg/kg | Experimental | Biological: JS019repeat dose every 21 days up |
| JS019 3 mg/kg | Experimental | Biological: JS019repeat dose every 21 days up |
| JS019 10 mg/kg | Experimental | Biological: JS019repeat dose every 21 days up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS019Four 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. | Biological | JS019 0.3 mg/kg, JS019 1 mg/kg, JS019 10 mg/kg, JS019 3 mg/kg |
Primary outcome
Safety and tolerability
Time frame: 2 years
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
Maximum tolerated dose (MTD, if possible) and the recommended phase 2 dose (RP2D)
Time frame: 2 years
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.
9 secondary outcomes
Pharmacokinetics (PK)
Time frame: 2 years
Immunogenicity
Time frame: 2 years
Pharmacodynamics （PD）
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS019 in people with Advanced Solid Tumors or Lymphomas, run by Suzhou Kebo Ruijun Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lin shen, Doctor of medicine (8610-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.