Actively Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-06-19
374
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.
CONDITIONS
Official Title
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects of either sex who are 18 to 75 years of age (inclusive of 18 and 75 years) at the time of signing the consent form
- Histologically or cytologically confirmed advanced malignant solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Expected survival of 63 12 weeks
- Subjects have at least 1 measurable lesion according to RECIST v1.1 criteria (without measurable lesions are allowed during dose escalation phase)
You will not qualify if you...
- Presence of active central nervous system metastasis unless stable for 4 weeks after treatment and hormone therapy stopped 2 weeks before first dose; meningeal or brainstem metastasis not allowed
- Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated management
- Medically uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- History of non-infectious interstitial lung disease or pneumonia requiring steroid therapy, or current such lung conditions
- Clinically significant lung-specific co-morbidities including recent lung disease or autoimmune diseases affecting lungs, and prior total pneumonectomy
- History of immunodeficiency including positive HIV test or history of allogeneic organ or stem cell transplantation
- Other serious physical or mental illnesses or abnormal labs that increase study risk or affect compliance, as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Z
Zhihao Jiang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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