Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of JS015 in patients with advanced solid tumors. The Recommended dose for phase II trial (RP2D) was determined based on the safety, pharmacokinetics, and initial efficacy data of the dose escalation and extension.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS015 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS015 | Drug | Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| dose-limiting toxicity (DLT)、adverse event(AE)、serious adverse event(SAE) | incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), Abnormal changes in laboratory and other tests with clinical significance | 2Years |
| Maximum tolerated dose (MTD),RP2D | Maximum tolerated dose (MTD), Recommended dose for phase II trial | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration(Cmax) | The highest plasma drug concentration that can be achieved after medication | 2 years |
| time to peak(Tmax) | After a single dose, the time of peak blood concentration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Xu, Project manager | Contact | +86 13761020175 | kai_xu@junshipharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li, Medical Doctor | Affiliation: Shanghai Oriental Hospital | Principal Investigator |
| Jinming Yu, Medical Doctor | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single Group
Not provided
Not provided
Not provided
Not provided
| 2 years |
| elimination half life(t1/2) | the time it takes the blood to reduce the concentration of the drug to half | 2 years |
| immunogenicity | Incidence of Anti-Drug Antibody (ADA) | 2 years |
| Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) | Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) | 2 years |
| overall survival (OS) | The time from randomization to death from any cause | 2 years |
| Affiliated Cancer Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
|
| Shanghai Oriental Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
|