Clinical Study of JS007 in Patients With Advanced Solid Tumors

NCT05049265 | Unknown Phase 1

• 1 other identifier: JS007-001-I
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 therapeutic regimen. This study is divided into two periods: dose escalation period, dose expansion period.

Conditions

Patients With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (6)

• MTD

  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

  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

  AE is assessed according to NCI-CTCAE 5.0

  Up to 12 approximately months

• Serious Adverse Events

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

  Up to 12 approximately months

• Incidence of immune-related adverse events (irAE)

  IrAE is assessed according to NCI-CTCAE 5.0

  Up to 12 approximately months

• severity of immune-related adverse events (irAE)

  IrAE is assessed according to NCI-CTCAE 5.0

  Up to 12 approximately months

Secondary Outcomes (15)

• peak concentration (Cmax)

  Up to 12 approximately months

• trough concentration (Ctrough)

  Up to 12 approximately months

• time to peak (Tmax)

  Up to 18 approximately months

• 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)

  Up to 12 approximately months

Other Outcomes (10)

• ORR

  Up to 12 approximately months

• DOR

  Up to 12 approximately months

• DCR

  Up to 12 approximately months

Study Arms (1)

JS007

EXPERIMENTAL

Biological: JS007

Interventions

JS007 BIOLOGICAL

JS007 only

JS007

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medical

Shanghai, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39354625 DERIVED

Central Study Contacts

Pan He, Postgraduate

CONTACT

8615172333540; pan_he@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 20, 2021
• Study Start: November 17, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-08

Locations

CN (1)