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Patients With Advanced Solid TumorsPhase 1NCT05049265

Clinical Study of JS007 in Patients With Advanced Solid Tumors

A Phase 1 study testing JS007 in people with Patients With Advanced Solid Tumors, run by Shanghai Junshi Bioscience 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 The sponsor has not verified this record for over two years, so it may be out of date.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 an open label, phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS007 in the patients with advanced solid tumors who have progressed after standard of care, or lack of effective standard… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Patients With Advanced Solid Tumors
What is being tested?
JS007
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
17 Nov 2021to 20 Sep 2022
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

  • Male or female patients with age of 18~75 years;
  • Signed informed consent form;
  • Confirmed histological or cytological diagnosis of advanced or recurrent solid tumor with previous standard therapy failure, no available standard therapy or refusal of standard therapy;
  • Consent to provide tumor tissue (FFPE archival sample within 2 years, or newly obtained tissue blocks, or unstained slides from FFPE);
  • Having at least one measurable lesion in accordance with the response evaluation criteria in solid tumors (RECIST V1.1).
  • Life expectancy ≥ 3 months;
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1 (Appendix 1);
  • Functional indicators of organs must fulfill the following criteria:
  • White blood cell ≥ 2.5 × 109/L ii. Neutrophils ≥ 1.5 × 109/L iii. Platelets ≥ 85 × 109/L iv. Hemoglobin ≥ 90 g/L v. Blood creatinine ≤ 1.5 × ULN, or creatinine clearance > 40 ml/min (calculated according to Cockcroft-Gault formula, see Appendix) vi. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN (for known liver metastases: AST and ALT ≤ 5×ULN) vii. Total bilirubin ≤ 1.5 × ULN (For subjects with Gilbert's Syndrome or known liver metastases, ≤ 2×ULN is acceptable)

Who cannot join

  • The patient with metastasis to the central nervous system (CNS);
  • The patient requires systemic steroids or anti-convulsant drugs, or patients with risk of intracerebral hemorrhage judged by the investigator;
  • Patients with primary CNS tumor or meningeal metastasis;
  • Having used systemic anticancer therapy, including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy, within 4 weeks prior to the first dose, or all adverse events except hair loss have not recovered to CTCAE Grade 1 or below;
  • Having other not curable cancers in the past 5 years, excluding the cured or treatable ones, such as basal skin carcinoma, squamous cell skin carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc;
  • Active autoimmune diseases required systemic treatment in the past 2 years, excluding vitiligo, type I diabetes, and autoimmune thyroiditis indued hypothyroidism that is curable by thyroid hormone replacement therapy;
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  • Active tuberculosis (TB);
  • Confirmed infection of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
  • Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):
  • HBsAg positive and HBV DNA ≥ 1000 IU/mL;
  • Positive test results of HCV RNA.
  • Women who are pregnant or breastfeeding;
  • Patients who are unavailable for venipuncture and/or intolerable for intravenous catheterization;
  • Interstitial lung disease;
  • History or basis of any clinically significant cardiovascular diseases as follows: abnormal electrocardiogram indicating additional risk for patients at the discretion of investigator; history of congestive heart failure (CHF) of grade III or above as documented by New York Heart Association (NYHA) criteria; history of cerebral infarction or myocardial infarction within 3 months prior to first dose; uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); unstable angina; serious uncontrolled arrhythmia; baseline left ventricular ejection fraction (LVEF) < 50% or cardiac wall motion abnormalities identified by echocardiogram (ECHO).
  • Patients accepting other study drugs or anti-infective vaccine (e.g., influenza vaccine, and varicella vaccine) within 28 days prior to the first dose, and COVID-19 （Corona Virus Disease 2019）vaccine is permitted
  • Patients with anti-tumor vaccine therapy within 3 months prior to the first dose, and prophylactic HPV（human papilloma virus） vaccine is permitted;
  • Previous treatment with anti-CTLA-4 drugs;
  • Patients accepting systemic corticosteroids treatment at the doses of immunosuppressive effects (prednisone > 10 mg/day or equivalent level) within 2 weeks before the first dose; patients accepting immunosuppressive agents or glucocorticoids (at doses equivalent to prednisone > 10 mg/day) within 2 weeks before the first dose. Note: Epinephrine replacement therapy (equivalent to prednisone ≤ 10 mg/day) is allowed for patients without active immune disorder . Topical, intraocular, intra-articular, intranasal, and inhaled corticosteroids, which lead to (low systemic absorption, are allowed; short-term corticosteroids treatment is allowed for prophylactic therapy (e.g., be allergic to contrast media) or non-autoimmune diseases (e.g., delayed hypersensitivity reactions after exposure to allergens).
  • Patient accepting any antitumor traditional Chinese patent medicine within 2 weeks prior to the first dose (any antitumor traditional Chinese patent medicine is prohibited during this study).
  • Active infection requiring systematic treatment/antibiotics. Patient accepting intravenous anti-infective therapy with one week prior to the first dose or undergoing systematic anti-infective agents ≥ 7 days;
  • Received live attenuated vaccines within 4 weeks prior to the first dose, or plan to receive live attenuated vaccines during the study;
  • Allergic to any component of JS007;
  • Patients are not ineligible if meet at least one of the following conditions prior to the first dose :
  • Major surgery requiring general anesthesia within 4 weeks prior to the first dose; ii. Surgery requiring local/epidural anesthesia within 72 hours prior to the first dose; iii. Skin biopsy requiring local anesthesia within 1 hour prior to the first dose.
  • Patients who are not appropriate for this trial due to other reasons at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

Pan He, Postgraduate contact

8615172333540

pan_he@junshipharma.com

China1 site, 1 recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medical

    Shanghai, 200025

    Yan Shi, PhD, shibaiwan12@vip.sina.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ia Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single-dose and Multiple-dose Of JS007 Injection In Patients With Advanced Solid Tumors

This is an open label, phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS007 in the patients with advanced solid tumors who have progressed after standard of care, or lack of effective standard therapeutic regimen. This study is divided into two periods: dose escalation period, dose expansion period.

Being tested
JS007

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS007Biological

    JS007 only

Study groups in NCT05049265
Study groupRoleWhat they receive
JS007ExperimentalNot described
Receives: Biological: JS007

What is being measured

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

  1. MTD

    The maximum tolerated dose (MTD) is defined as the highest dose at which DLT （Dose-Limiting Toxicity）occurs in <1/3 subjects

    Measured: Up to 12 approximately months

  2. DLT

    DLT is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 21 days after the first dose (NCI-CTCAE v5.0)

    Measured: 21 days after first infusion of study drug

  3. Adverse Events

    AE is assessed according to NCI-CTCAE 5.0

    Measured: Up to 12 approximately months

  4. Serious Adverse Events

    SAE（Serious adverse event） is assessed according to NCI-CTCAE 5.0

    Measured: Up to 12 approximately months

  5. Incidence of immune-related adverse events (irAE)

    IrAE is assessed according to NCI-CTCAE 5.0

    Measured: Up to 12 approximately months

  6. severity of immune-related adverse events (irAE)

    IrAE is assessed according to NCI-CTCAE 5.0

    Measured: Up to 12 approximately months

Secondary outcomes (15)

  1. peak concentration (Cmax)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);

    Measured: Up to 12 approximately months

  2. trough concentration (Ctrough)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough)

    Measured: Up to 12 approximately months

  3. time to peak (Tmax)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);

    Measured: Up to 18 approximately months

  4. area under the plasma drug concentration-time curve (AUC0-t )

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-t )

    Measured: Up to 12 approximately months

  5. area under the plasma drug concentration-time curve (AUC0-inf)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-inf);

    Measured: Up to 12 approximately months

  6. elimination half-life (t1/2)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2)

    Measured: Up to 12 approximately months

  7. clearance rate (CL)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);

    Measured: Up to 12 approximately months

  8. apparent volume of distribution(Vd)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; apparent volume of distribution(Vd)

    Measured: Up to 12 approximately months

  9. volume of distribution (Vss)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss)

    Measured: Up to 12 approximately months

  10. mean retention time (MRT)

    Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT)

    Measured: Up to 12 approximately months

  11. The number of lymphocyte in peripheral blood before and after administration

    The number of lymphocyte in peripheral blood before and after administration

    Measured: Up to 12 approximately months

  12. The proportion of lymphocyte in peripheral blood before and after administration

    The proportion of lymphocyte in peripheral blood before and after administration

    Measured: Up to 12 approximately months

  13. anti-drug body (ADA)

    incidence of anti-drug body (ADA)

    Measured: Up to 12 approximately months

  14. neutralizing antibody (Nab)

    incidence of neutralizing antibody (Nab)

    Measured: Up to 12 approximately months

  15. neutralizing antibody (Nab)

    concentration of neutralizing antibody (Nab)

    Measured: Up to 12 approximately months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start17 Nov 2021
  3. Primary completion20 Sep 2022 (estimated)
  4. Study completion20 Sep 2022 (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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049265
Sponsor's protocol ID
JS007-001-I
Status last verified
Aug 2021
First submitted
19 Aug 2021
Last updated
23 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou C, Jiang J, Xiang X, Liu H, Wu G, Zeng R, Lu T, Zhang M, Shen Y, Hong M, Zhang J. Preclinical investigations and a first-in-human phase 1a trial of JS007, a novel anti-CTLA-4 antibody, in patients with advanced solid tumors. Exp Hematol Oncol. 2024 Oct 1;13(1):98. doi: 10.1186/s40164-024-00567-7.

    PubMed 39354625

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS007 in people with Patients With Advanced Solid Tumors, run by Shanghai Junshi Bioscience 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 9 inclusion and 26 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 23 Nov 2021. 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 Pan He, Postgraduate (8615172333540, pan_he@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: Up to 12 approximately months). The study lists 6 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 NCT05049265, which also lists 1 linked publication.

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 23 Nov 2021.

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