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A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced Pancreatic Cancer

Primary Purpose

Advanced Pancreatic Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JS107
JS107 combination with Toripalimab
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subjects voluntarily participated in the study with full informed consent and signed written informed consent form; Aged ≥18 years and ≤75 years when the subject signed the informed consent; Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ; Provide past tumor samples or fresh tumor tissue biopsy samples; The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale; The expected survival is ≥3 months; There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria; 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; Good organ function; 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: Prior treatment with drugs or other therapies targeting CLDN18.2; A history of severe allergic reactions to to any component of JS107; 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; 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); Serious infection (CTCAE> grade 2) occurred within 14 days before the first dose; 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.); Major organ surgery was performed or significant trauma was present within 4 weeks before the first administration of the study drug; 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. 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; Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms, signs or requiring symptomatic treatment; Poorly controlled pain related; 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; 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); Pregnant or lactating women; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Have serious psychological or mental abnormality, which affects the compliance of the subject to participate in this clinical study; 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 ; History of autoimmune disease; 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; Received any live vaccine (e.g. influenza vaccine against infectious diseases, chickenpox vaccine, etc.) within 14 days before first dose; Other conditions deemed inappropriate for study participation by the investigator.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

JS107

JS107 combination with Toripalimab

Arm Description

Outcomes

Primary Outcome Measures

MTD
Determine maximum tolerated dose (MTD, if possible)
RP2D
Recommended phase II dose (RP2D) for JS107 monotherapy and combination therapy

Secondary Outcome Measures

Drug concentrations in plasma
Drug concentrations in individual subjects at different time points after dosing
Immunogenicity
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples
ORR
Objective response rate (ORR) was assessed based on RECIST V1.1 criteria

Full Information

First Posted
December 12, 2022
Last Updated
December 19, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05657418
Brief Title
A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced Pancreatic Cancer
Official Title
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2022 (Anticipated)
Primary Completion Date
September 25, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Sequential
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JS107
Arm Type
Experimental
Arm Title
JS107 combination with Toripalimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JS107
Intervention Description
JS107, i.v., q3w
Intervention Type
Combination Product
Intervention Name(s)
JS107 combination with Toripalimab
Intervention Description
JS107 i.v., q3w combine with Toripalimab
Primary Outcome Measure Information:
Title
MTD
Description
Determine maximum tolerated dose (MTD, if possible)
Time Frame
Up to approximately 12 months from first patient in.
Title
RP2D
Description
Recommended phase II dose (RP2D) for JS107 monotherapy and combination therapy
Time Frame
Up to approximately 24 months from first patient in.
Secondary Outcome Measure Information:
Title
Drug concentrations in plasma
Description
Drug concentrations in individual subjects at different time points after dosing
Time Frame
Up to approximately 24 months from first patient in.
Title
Immunogenicity
Description
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples
Time Frame
Up to approximately 24 months from first patient in.
Title
ORR
Description
Objective response rate (ORR) was assessed based on RECIST V1.1 criteria
Time Frame
Up to approximately 24 months from first patient in.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects voluntarily participated in the study with full informed consent and signed written informed consent form; Aged ≥18 years and ≤75 years when the subject signed the informed consent; Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ; Provide past tumor samples or fresh tumor tissue biopsy samples; The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale; The expected survival is ≥3 months; There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria; 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; Good organ function; 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: Prior treatment with drugs or other therapies targeting CLDN18.2; A history of severe allergic reactions to to any component of JS107; 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; 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); Serious infection (CTCAE> grade 2) occurred within 14 days before the first dose; 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.); Major organ surgery was performed or significant trauma was present within 4 weeks before the first administration of the study drug; 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. 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; Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms, signs or requiring symptomatic treatment; Poorly controlled pain related; 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; 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); Pregnant or lactating women; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Have serious psychological or mental abnormality, which affects the compliance of the subject to participate in this clinical study; 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 ; History of autoimmune disease; 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; Received any live vaccine (e.g. influenza vaccine against infectious diseases, chickenpox vaccine, etc.) within 14 days before first dose; Other conditions deemed inappropriate for study participation by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohong Ding, PM
Phone
86 021-61058800
Email
xiaohong_ding@junshipharma.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D
Phone
86 021-64175590
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D.
First Name & Middle Initial & Last Name & Degree
Jian Zhang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced Pancreatic Cancer

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