About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ≥ 12 weeks;
Disqualifiers
Presence of active central nervous system metastasis. If previous radiotherapy or surgery, etc. has been received, and the imaging examination within 4 weeks before the first dose suggests that the brain metastasis is stable without exacerbation or new neurological symptoms, and hormone therapy has been discontinued two weeks before the first dose, screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, regardless of the treatment or not, screening is not allowed;
Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);
Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;
Presence of a history of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid therapy (e.g., idiopathic pulmonary fibrosis, mechanized pneumonia, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia, etc.), and current ILD/non-infectious pneumonia;
Trial design
Sequential
Treatments tested in this trial
JS212 for Injection
DrugJS212 for Injection is administered on the first day of the first cycle and every 3 weeks thereafter.
Treatment groups
Trial outcomes
Primary outcomes
DLT
Incidence and severity of DLT events
Incidence and severity of Adverse Events
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
MTD
Maximum tolerated dose
RP2D
Recommended phase II dose
Secondary outcomes
DOR
Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1
DCR
Investigator-assessed Duration of objective Response (DCR) according to RECIST v1.1
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1
Overall Survival (OS)
Overall Survival (OS)
Other outcomes
To explore the correlation between potential MARKERS and efficacy
To explore the correlation between potential MARKERS and efficacy
To explore the correlation between serum β-Glucuronidase Concentrations and efficacy
To explore the correlation between serum β-Glucuronidase Concentrations and efficacy
Sponsors and contacts
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