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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Cancer
• Intervention / Treatment: Drug: JS015

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kai Xu, Project manager; Phone Number: +86 13761020175; Email: kai_xu@junshipharma.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Lin Shen, Medical Doctor; Phone Number: 86 010-898196561; Email: doctorshenlin@sina.cn
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Affiliated Cancer Hospital of Harbin Medical University
      • Contact: Tongsen Zheng, Medical Doctor; Phone Number: 86 0451-86298975; Email: zhengtongsen@126.com
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Yuping Sun, Medical Doctor; Phone Number: 86 0531-67627156; Email: 13370582181@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai Oriental Hospital
      • Contact: Jin Li, Medical Doctor; Phone Number: 86 021-38804518; Email: lijin@csco.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing to participate in this study and provide written informed consent;
2. Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment;
3. At least one measurable lesion according to RECIST 1.1;
4. Life expectancy ≥ 3 months;
5. Eastern Cooperative Oncology Group (ECOG) 0 or 1;
6. Adequate organ function;
7. Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be ≤ grade 1;
8. 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:

1. Allergy or contraindication to JS015 and its ingredients;
2. Has a known additional malignancy in the last 5 years.
3. Pregnancy or lactation;
4. History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
5. Brain or meningeal metastases
6. Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage)
7. Severe cardiovascular and cerebrovascular diseases;
8. Previous antineoplastic therapy meets washout requirements.
9. 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 ;
10. Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV);
11. moderate to severe that seriously affect lung function;
12. Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JS015	Drug: JS015; Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.
• Collaborators: Sponsor GmbH
• Investigators: Principal Investigator: Jin Li, Medical Doctor, Affiliation: Shanghai Oriental Hospital; Principal Investigator: Jinming Yu, Medical Doctor, Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JS015-001-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No