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Advanced Solid TumorsPhase 1NCT05508373

A Clinical Study to Evaluate the Safety, Tolerability,JS019 in Patients With Advanced Solid Tumors

A Phase 1 study testing JS019 in people with Advanced Solid Tumors, run by Suzhou Kebo Ruijun Biotechnology Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 The study includes JS019 monotherapy dose escalation, dose expansion stages to investigate the safety, tolerability, pharmacokinetics… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
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
72 participants
Where
1 siteChina
Study dates
29 Mar 2022to 10 Aug 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
  • Failed or unsuitable for standard 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 ;

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.);

Trial locations and contacts

1 site in 1 country.

Yilong Wu, bachelor's degree contact

86020-83877855

syylwu@live.cn

Huajun Chen, Doctor of Medicine contact

8613710581145

chenhuajun@gdph.org.cn

China1 site, 1 recruiting

  • Guangdong General Hospital

    Guangdong, Guangzhou, 510062

    Yilong Wu, bachelor's degree, 86020-83877855, syylwu@live.cn

    Huajun Chen, Doctor of Medicine

    Recruiting

Other trials in China

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

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.

Read the 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.

Being tested
JS019

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 groups in NCT05508373
Study groupRoleWhat they receive
Dose Escalation: dose level：0.3mg/kgExperimentalDose Escalation: 0.3mg/kg, IV infusion, every 3 weeks (q3w).
Receives: Biological: JS019
Dose Escalation: dose level：1 mg/kgExperimentalDose Escalation: 1 mg/kg IV infusion, every 3 weeks (q3w).
Receives: Biological: JS019
Dose Escalation: dose level：3 mg/kgExperimentalDose Escalation: 3 mg/kg IV infusion, every 3 weeks (q3w).
Receives: Biological: JS019
Dose Escalation: dose level：10 mg/kgExperimentalDose Escalation: 10 mg/kg IV infusion, every 3 weeks (q3w).
Receives: Biological: JS019

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

  2. 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.

    Measured: 2 years

Secondary outcomes (9)

  1. Pharmacokinetics (PK)

    Drug concentrations in individual subjects at different time points after administration

    Measured: 2 years

  2. Immunogenicity

    Incidence of anti-drug antibodies (ADA), titer of ADA-positive samples.

    Measured: 2 years

  3. Pharmacodynamics （PD）

    CD39 receptor occupancy in peripheral blood.

    Measured: 2 years

  4. Objective response rate (ORR)

    The percentage of cases with remission (PR + CR) after treatment was assessable

    Measured: 2 years

  5. 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

  6. Disease control rate (DCR)

    The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.

    Measured: 2 years

  7. Time to response (TTR)

    time from the start of treatment to progression of diease.

    Measured: 2 years

  8. Progression-free survival (PFS)

    PFS is defined as time from the start of treatment to progression of disease or death.

    Measured: 2 years

  9. 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.

  1. First posted19 Aug 2022
  2. Study start29 Mar 2022
  3. Primary completion15 Jun 2024 (estimated)
  4. Study completion10 Aug 2024 (estimated)

Resources

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
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508373
Sponsor's protocol ID
JS019-002-I
Status last verified
Apr 2022
First submitted
10 Aug 2022
Last updated
19 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS019 in people with Advanced Solid Tumors, 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 5 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 19 Aug 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 Yilong Wu, bachelor's degree (86020-83877855, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Incidence of DLT severity of adverse events (AEs) and serious adverse events (SAEs)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?

On the ClinicalTrials.gov record for NCT05508373.

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 19 Aug 2022.

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