The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    176
  • sponsor
    Shanghai Junshi Bioscience Co., Ltd.
Updated on 6 October 2021

Summary

This is an open-label, dose-escalation and dose-expansion phase I clinical study to evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies or who have no standard therapy. It is planned to enroll 69-176 patients into the study.

Details
Condition Advanced Tumors
Treatment JS006 as Monotherapy, JS006 in combination with Toripalimab
Clinical Study IdentifierNCT05061628
SponsorShanghai Junshi Bioscience Co., Ltd.
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Understanding and signature of the informed consent form voluntarily
Age 18 - 75 years (inclusive), male or female
Pathologically confirmed advanced malignancy who have failed standard treatment or with no standard treatment available
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected survival 12 weeks
Having at least one measurable lesion that meets RECIST v1.1 criteria or Lugano 2014 criteria
The function of vital organs meets the following requirements (no blood transfusion or blood products and no hematopoietic stimulating factors and other drugs to correct blood cell counts within 14 days before the examination)
-1.Absolute neutrophil count (ANC) 1.5 109/L; 7-2. Platelet count (PLT) 90
L; 7-3.Hemoglobin (Hb) 90 g/L; 7-4.Total bilirubin (TBIL) 1.5 ULN, or for
patients with liver metastases or Gilbert syndrome, TBIL 3 ULN; 7-5.Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) 3 ULN, or for
patients with liver metastases, ALT and AST 5 ULN; 7-6.Serum creatinine (Cr)
5 ULN, or calculated creatinine clearance (Cockcroft-Gault formula) 50
mL/min; 7-7.For patients not receiving anticoagulant therapy, international
normalized ratio (INR), prothrombin time (PT) and activated partial
thromboplastin time (aPTT) 1.5 ULN; For patients receiving anticoagulation
therapy (such as low molecular weight heparin or warfarin) require a stable
dose of anticoagulant drugs for at least 4 weeks without dose adjustment
-8.QTc interval calculated according to Fridericia's criteria 450 ms for
males and 470 ms for females
\. Female patients of childbearing potential and male patients whose partners
are women of childbearing potential are willing to use effective contraceptive
measures during the study treatment and for 6 months after the last dose
Female patients of childbearing potential must have a negative serum HCG test
within 7 days before study enrollment and must be non-lactating. The
childbearing potential is defined as a woman who has not undergone surgical
sterilization, hysterectomy and/or bilateral oophorectomy or who is not
postmenopausal (amenorrhea 12 months)

Exclusion Criteria

Patients who met any of the following criteria will be excluded from the
study
Known allergic to toripalimab or ingredients of JS006
Have received anti-TIGIT or related targets CD155, CD112 or CD113 antibody treatment in the past
Participation in other clinical studies within 4 weeks before the first dose, except for an observational (non-interventional) clinical study or follow-up period of an interventional study
Major surgery (as judged by the investigator) within 4 weeks before the first dose or in the recovery period of surgery
Received systemic anti-tumor therapy within 4 weeks before the first dose, such as chemotherapy (or within 6 weeks for the last chemotherapy with nitrosourea or mitomycin), radiotherapy, targeted therapy, immunotherapy or biological therapy. Received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose of JS006. Hormone therapy, such as insulin for diabetes, hormone replacement therapy, etc., is acceptable for non-tumor-related diseases. Local palliative treatment (such as local surgery or radiotherapy) for isolated lesions can be accepted without affecting the efficacy evaluation
Patients who discontinued prior immunotherapy due to immune-related adverse reactions
Received immunosuppressive medications within 4 weeks before the first dose, except corticosteroid nasal spray, inhalers, or systemic prednisone 10 mg/day or equivalent
Received allogeneic bone marrow transplantation or solid organ transplantation in the past
Patients who received live attenuated vaccination within 30 days before the first dose
Patients with two or more malignancies within 5 years before the first dose, except for early malignancy (carcinoma in situ or stage I tumors) that have been cured, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer
Presence of central nervous system (CNS) metastases that are symptomatic, untreated, or require continued treatment (including corticosteroids and antiepileptic drugs). Patients who previously received treatment but were clinically stable for at least 4 weeks before enrollment can be enrolled, excluding patients with evidence of new or expanded metastasis and discontinued steroid therapy
The toxicity has not resolved after prior anti-tumor therapy, which means do not recover to baseline, NCI-CTCAE 5.0 Grade 0 to 1 (except alopecia, pigmentation) or the level specified in the inclusion/exclusion criteria. Irreversible toxicity (such as hearing loss) that is reasonably not expected to be aggravated by the study drug can be enrolled after consultation with the medical monitor
Patients with autoimmune disorder within the previous 2 years, including but not limited to systemic lupus erythematosus or multiple sclerosis
History of immediate allergic reactions, eczema or asthma uncontrolled by topical corticosteroids
History of primary immunodeficiency
Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever > 38.5C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) < 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis
History of active tuberculosis, drug-induced interstitial lung disease, or Grade 2 pulmonitis
History of active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
Patients with human immunodeficiency virus (HIV) positive
Active hepatitis B or C. Active hepatitis B is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above the upper limit of normal at the study site; Active hepatitis C is defined as positive hepatitis C antibody and HCV RNA level above the upper limit of normal at the study site
Patients with endocrine defects that have been controlled by hormone replacement therapy can be enrolled, such as type I diabetes, hypothyroidism, etc. The following patients should be evaluated for target organ involvement and the need for systemic therapy at the discretion of the investigator, such as patients with concurrent rheumatoid arthritis and other joint diseases, Sjogren's syndrome, celiac disease and psoriasis that have been controlled after topical medication, as well as patients with positive serological tests e.g. antinuclear antibodies (ANA), anti-thyroid antibodies, etc
Other conditions are considered not suitable for the study by the investigator
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