Status:
UNKNOWN
A Phase 1 Study to Evaluate JS019 in Advanced Solid Tumors or Lymphomas
Lead Sponsor:
Suzhou Kebo Ruijun Biotechnology Co., Ltd
Conditions:
Advanced Solid Tumors or Lymphomas
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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/lymphomas. Th...
Detailed Description
Monotherapy Dose Escalation Stage: In this stage, the safety and tolerability, PK characteristics, immunogenicity and PD of JS019 are investigated. Four dose levels are preset: 0.3 mg/kg, 1 mg/kg, 3 ...
Eligibility Criteria
Inclusion
- 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 or lymphomas;
- Failed or unsuitable for standard treatment, received at least one line of systemic 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 or Lugano 2014;
Exclusion
- 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.);
- Patients who have discontinued immunotherapy due to immune-related AEs.
- Patients who have used immunosuppressive drugs within 4 weeks prior to the first dose of JS019, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids ≤10 mg/day prednisone or equivalent.
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2024
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05374226
Start Date
March 31 2022
End Date
March 7 2024
Last Update
May 16 2022
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142