To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase I Study Of JS015 in Patients With Advanced Solid Tumors
NCT ID:
NCT05770310
Condition:
Advanced Solid Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JS015
Description:
Patient receives specific dose of JS015. The administration method of JS015 is
intravenous infusion.
Arm group label:
JS015
Summary:
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.
Criteria for eligibility:
Criteria:
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.,
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, Medical Doctor
Phone:
86 010-898196561
Email:
doctorshenlin@sina.cn
Facility:
Name:
Affiliated Cancer Hospital of Harbin Medical University
Address:
City:
Ha'erbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tongsen Zheng, Medical Doctor
Phone:
86 0451-86298975
Email:
zhengtongsen@126.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuping Sun, Medical Doctor
Phone:
86 0531-67627156
Email:
13370582181@163.com
Facility:
Name:
Shanghai Oriental Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li, Medical Doctor
Phone:
86 021-38804518
Email:
lijin@csco.org.cn
Start date:
February 1, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Sponsor GmbH
Agency class:
Other
Source:
Shanghai Junshi Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05770310
