Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05657418
Other study ID # JS107-002-I
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date December 30, 2022
Est. completion date December 30, 2024

Study information

Verified date October 2022
Source Shanghai Junshi Bioscience Co., Ltd.
Contact Xiaohong Ding, PM
Phone 86 021-61058800
Email xiaohong_ding@junshipharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 pancreatic cancer.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 106
Est. completion date December 30, 2024
Est. primary completion date September 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 to any component of JS107; 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. Serious infection (CTCAE> grade 2) occurred within 14 days before the first dose; 6. 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.); 7. Major organ surgery was performed or significant trauma was present within 4 weeks before the first administration of the study drug; 8. 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. 9. 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; 10. Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms, signs or requiring symptomatic treatment; 11. Poorly controlled pain related; 12. 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; 13. 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); 14. Pregnant or lactating women; 15. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Have serious psychological or mental abnormality, which affects the compliance of the subject to participate in this clinical study; 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. History of autoimmune disease; 19. 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; 20. Received any live vaccine (e.g. influenza vaccine against infectious diseases, chickenpox vaccine, etc.) within 14 days before first dose; 21. Other conditions deemed inappropriate for study participation by the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
JS107
JS107, i.v., q3w
Combination Product:
JS107 combination with Toripalimab
JS107 i.v., q3w combine with Toripalimab

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MTD Determine maximum tolerated dose (MTD, if possible) Up to approximately 12 months from first patient in.
Primary RP2D Recommended phase II dose (RP2D) for JS107 monotherapy and combination therapy Up to approximately 24 months from first patient in.
Secondary Drug concentrations in plasma Drug concentrations in individual subjects at different time points after dosing Up to approximately 24 months from first patient in.
Secondary Immunogenicity Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples Up to approximately 24 months from first patient in.
Secondary ORR Objective response rate (ORR) was assessed based on RECIST V1.1 criteria Up to approximately 24 months from first patient in.
See also
  Status Clinical Trial Phase
Recruiting NCT05028933 - IMC001 for Clinical Research on Advanced Digestive System Malignancies Phase 1
Not yet recruiting NCT03662035 - Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer Phase 2
Recruiting NCT05085548 - ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies Phase 1
Recruiting NCT06111274 - A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT04137536 - A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer Phase 1
Completed NCT04617067 - Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT04469556 - Pancreatic Adenocarcinoma Signature Stratification for Treatment Phase 2
Recruiting NCT04104672 - A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies Phase 1
Not yet recruiting NCT05100329 - A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer Phase 2
Completed NCT02101580 - Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer Phase 1
Not yet recruiting NCT06329947 - A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD Phase 2
Recruiting NCT02135822 - Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer Phase 2
Recruiting NCT04803851 - Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT03415802 - Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer Phase 2
Recruiting NCT05162118 - Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer Phase 1/Phase 2
Recruiting NCT04643405 - APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma Phase 1/Phase 2
Recruiting NCT03889795 - Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors Phase 1
Completed NCT01303172 - A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer Phase 2
Not yet recruiting NCT06422156 - SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT04931381 - Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer Phase 3