- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05049265
Clinical Study of JS007 in Patients With Advanced Solid Tumors
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Pan He, Postgraduate
- Phone Number: 8615172333540
- Email: pan_he@junshipharma.com
Study Locations
-
-
-
Shanghai, China, 200025
- Recruiting
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medical
-
Contact:
- Yan Shi, PhD
- Email: shibaiwan12@vip.sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1 (Appendix 1);
Functional indicators of organs must fulfill the following criteria:
i. 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)
Exclusion criteria:
- 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;
- 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 :
i. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JS007
|
JS007 only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD
Time Frame: Up to 12 approximately months
|
The maximum tolerated dose (MTD) is defined as the highest dose at which DLT (Dose-Limiting Toxicity)occurs in <1/3 subjects
|
Up to 12 approximately months
|
DLT
Time Frame: 21 days after first infusion of study drug
|
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)
|
21 days after first infusion of study drug
|
Adverse Events
Time Frame: Up to 12 approximately months
|
AE is assessed according to NCI-CTCAE 5.0
|
Up to 12 approximately months
|
Serious Adverse Events
Time Frame: Up to 12 approximately months
|
SAE(Serious adverse event) is assessed according to NCI-CTCAE 5.0
|
Up to 12 approximately months
|
Incidence of immune-related adverse events (irAE)
Time Frame: Up to 12 approximately months
|
IrAE is assessed according to NCI-CTCAE 5.0
|
Up to 12 approximately months
|
severity of immune-related adverse events (irAE)
Time Frame: Up to 12 approximately months
|
IrAE is assessed according to NCI-CTCAE 5.0
|
Up to 12 approximately months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peak concentration (Cmax)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);
|
Up to 12 approximately months
|
trough concentration (Ctrough)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough)
|
Up to 12 approximately months
|
time to peak (Tmax)
Time Frame: Up to 18 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);
|
Up to 18 approximately months
|
area under the plasma drug concentration-time curve (AUC0-t )
Time Frame: Up to 12 approximately months
|
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 )
|
Up to 12 approximately months
|
area under the plasma drug concentration-time curve (AUC0-inf)
Time Frame: Up to 12 approximately months
|
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);
|
Up to 12 approximately months
|
elimination half-life (t1/2)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2)
|
Up to 12 approximately months
|
clearance rate (CL)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);
|
Up to 12 approximately months
|
apparent volume of distribution(Vd)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; apparent volume of distribution(Vd)
|
Up to 12 approximately months
|
volume of distribution (Vss)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss)
|
Up to 12 approximately months
|
mean retention time (MRT)
Time Frame: Up to 12 approximately months
|
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT)
|
Up to 12 approximately months
|
The number of lymphocyte in peripheral blood before and after administration
Time Frame: Up to 12 approximately months
|
The number of lymphocyte in peripheral blood before and after administration
|
Up to 12 approximately months
|
The proportion of lymphocyte in peripheral blood before and after administration
Time Frame: Up to 12 approximately months
|
The proportion of lymphocyte in peripheral blood before and after administration
|
Up to 12 approximately months
|
anti-drug body (ADA)
Time Frame: Up to 12 approximately months
|
incidence of anti-drug body (ADA)
|
Up to 12 approximately months
|
neutralizing antibody (Nab)
Time Frame: Up to 12 approximately months
|
incidence of neutralizing antibody (Nab)
|
Up to 12 approximately months
|
neutralizing antibody (Nab)
Time Frame: Up to 12 approximately months
|
concentration of neutralizing antibody (Nab)
|
Up to 12 approximately months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: Up to 12 approximately months
|
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors), including objective response rate (ORR).
|
Up to 12 approximately months
|
DOR
Time Frame: Up to 12 approximately months
|
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including duration of response (DOR);
|
Up to 12 approximately months
|
DCR
Time Frame: Up to 12 approximately months
|
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including disease control rate (DCR);
|
Up to 12 approximately months
|
PFS
Time Frame: Up to 12 approximately months
|
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including progression-free survival (PFS)
|
Up to 12 approximately months
|
OS
Time Frame: Up to 12 approximately months
|
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including overall survival (OS);
|
Up to 12 approximately months
|
CTLA-4(cytotoxic T lymphocyte-associated antigen-4)
Time Frame: Up to 12 approximately months
|
Expression of CTLA-4 in tumor tissues before administration
|
Up to 12 approximately months
|
FoxP3(transcription factor Forkhead box P3)
Time Frame: Up to 12 approximately months
|
Expression of FoxP3 in tumor tissues before administration
|
Up to 12 approximately months
|
IDO((indoleamine 2,3-dioxy- genase)
Time Frame: Up to 12 approximately months
|
Expression of IDO in tumor tissues before administration
|
Up to 12 approximately months
|
mutation of immune related genes in tumor tissues before administration
Time Frame: Up to 12 approximately months
|
mutation of immune related genes in tumor tissues before administration
|
Up to 12 approximately months
|
expression of immune related genes in tumor tissues before administration
Time Frame: Up to 12 approximately months
|
expression of immune related genes in tumor tissues before administration
|
Up to 12 approximately months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS007-001-I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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