Trial Title:
A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors
NCT ID:
NCT05502393
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Sequential
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JS107
Description:
JS107, i.v., q3w
Arm group label:
JS107
Arm group label:
JS107 combination with Toripalimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab i.v., q3w
Arm group label:
JS107 combination with Toripalimab
Summary:
The purpose of this phase I clinical study was to evaluate the safety and tolerability of
JS107 monotherapy and combination with Toripalimab in patients with Advanced or
Metastatic Solid Tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subjects voluntarily participated in the study with full informed consent and
signed written informed consent form;
2. Aged ≥18 years and ≤75 years when the subject signed the informed consent;
3. Locally advanced unresectable or metastatic malignant solid tumors diagnosed
histologically ;
4. Provide past tumor samples or fresh tumor tissue biopsy samples;
5. The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG)
scale;
6. The expected survival is ≥3 months;
7. There should be at least one measurable lesion according to RECIST V1.1 evaluation
criteria;
8. Any adverse events and/or complications resulting from prior treatment, including
surgery or radiation therapy, that have been adequately resolved to level 0 or 1
(according to the NATIONAL Cancer Institute Standard for General Terminology of
Adverse Events (NCI-CTCAE 5.0) or to the level specified in the inclusion criteria;
Any grade of hair loss/pigmentation and other long-term toxicity caused by
treatment, except those that are irreversible and do not affect study
dosing/compliance and patient safety at the discretion of the investigator;
9. Good organ function;
10. Within 7 days prior to the first dose, women of reproductive age must be confirmed
as having a negative serum pregnancy test and consent to use effective contraception
during the duration of study drug use and for 6 months after the last dose. Male
patients with a female partner of reproductive age agreed to use effective
contraception during the study drug use period and for 6 months after the last dose.
Exclusion Criteria:
1. Prior treatment with drugs or other therapies targeting CLDN18.2;
2. A history of severe allergic reactions to other monoclonal antibodies or to any
component of JS107, or to other drugs or excipients involved in the trial protocol ;
3. Received radiotherapy (except palliative radiotherapy for symptom control),
chemotherapy, targeted therapy, endocrine therapy and other antitumor therapies, or
other investigational drugs within 4 weeks before the administration of the first
dose;
4. Received any monoclonal antibody or antibody conjugate within 4 weeks prior to
administration of the first study drug or within 5 half-lives (depend on whichever
is shorter);
5. Persons who have an immunodeficient disease or the other chronic immunosuppressive
therapy, or who have received systemic immunomodulatory drugs (including, but not
limited to, interferon or IL-2) within 14 days before first dose or within the 5
half-life of the drug (depend on whichever is longer), or received systemic
glucocorticoid therapy (10mg daily of prednisone or equivalent glucocorticoids) or
other systemic immunosuppressive therapy within 14 days before first dose;
6. Received any live vaccine (e.g. influenza vaccine against infectious diseases,
chickenpox vaccine, etc.) within 14 days before first dose;
7. Serious infection (CTCAE> grade 2) occurred within 14 days before the first dose;
8. Patients with other malignant tumors except for the tumor treated in the study
within 5 years prior to the administration of the first study drug (exceptions
included: cured malignancies that had not recurred within 3 years prior to study
enrollment; Completely resected basal and squamous cell skin cancers; Complete
resection of any type of carcinoma in situ, etc.);
9. Major organ surgery was performed or significant trauma was present within 4 weeks
before the first administration of the study drug;
10. Weight loss 10% within 2 months before drug administration, or other indicators of
severe malnutrition, or body mass index (BMI)<17.5 at the time of signing the
informed consent.
11. The following conditions were present within 6 months prior to the first study dose:
myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac
insufficiency, clinically significant supraventricular or ventricular arrhythmia,
and symptomatic congestive heart failure , hypertensive crisis, or hypertensive
encephalopathy; patients with known hypertension, coronary artery disease,
congestive heart failure not meeting the above criteria, or left ventricular
ejection fraction <50% must be treated with optimal stabilization as determined by
the treating physician medical plan;
12. Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms,
signs or requiring symptomatic treatment;
13. Poorly controlled pain related;
14. The presence of uncontrolled or symptomatic active central nervous system (CNS)
metastases, which can be manifested by the onset of clinical symptoms, cerebral
edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease,
and/or progressive growth;
15. Active infection, including tuberculosis (clinical diagnosis including clinical
history, physical examination and imaging findings, as well as TB tests according to
local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus
(HIV antibody positive);
16. History of autoimmune disease;
17. Idiopathic pulmonary fibrosis, drug-induced pneumonia, machine-induced pneumonia
(bronchiolitis obliterans), radioactive pneumonia with clinical symptoms or
requiring steroid treatment, active pneumonia, or other moderate to severe lung
diseases that seriously affect lung function ;
18. Pregnant or lactating women;
19. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell
transplantation;
20. Have serious psychological or mental abnormality, which affects the compliance of
the subject to participate in this clinical study;
21. Participated in any other clinical trial within 28 days prior to the first
administration of study drug;
22. Other conditions deemed inappropriate for study participation by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rongbo Lin, M.D.
Phone:
86 0591-83660063
Email:
Rongbo_lin@163.com
Investigator:
Last name:
Rongbo Lin, M.D.
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruihua Xu, M.D.
Phone:
86 020-87342479
Email:
xurh@sysucc.org.cn
Investigator:
Last name:
Ruihua Xu, Study Principal Investigator
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Zhejiang University Medical College
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianzhen Shan, M.D.
Phone:
86 0571-87236114
Email:
jianzhenshan@163.com
Investigator:
Last name:
Jianzhen Shan, M.D.
Email:
Principal Investigator
Start date:
July 26, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
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/NCT05502393