A Phase I Study Of JS015 in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS015 In Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Cancer

Intervention / Treatment
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* Drug: JS015


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to participate in this study and provide written informed consent; Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment; At least one measurable lesion according to RECIST 1.1; Life expectancy ≥ 3 months; Eastern Cooperative Oncology Group (ECOG) 0 or 1; Adequate organ function; Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be ≤ grade 1; Women of childbearing age must confirm that the serum pregnancy test is negative within 7 days before the first dose; Male and female patients of child bearing potential will to use abstinence or an effective method of contraception throughout the treatment period and for 90 days following the last dose of study drug; Exclusion Criteria: Allergy or contraindication to JS015 and its ingredients; Has a known additional malignancy in the last 5 years. Pregnancy or lactation; History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Brain or meningeal metastases Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage) Severe cardiovascular and cerebrovascular diseases; Previous antineoplastic therapy meets washout requirements. Severe infection (Criteria for the evaluation of common adverse events(CTC AE) 5.0>2 grade) occurred within 28 days before the first study administration; Active infection or unexplained fever > 38.5°C ; Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV); moderate to severe that seriously affect lung function; Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JS015<br> | Drug: JS015<br>* Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |