Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Leucovorin

Fluorouracil

Irinotecan

Immunomodulating Agents

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS004 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs.

Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS007 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs.

Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS015 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs.

Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS004 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs.

Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS007 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs.

Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS015 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs.

240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.

JS001

200 mg by IV infusion Q3W, given on cycle day 1.

JS004

3mg/kg by IV infusion Q3W, given on cycle day 1.

JS007

600mg by IV infusion Q3W, given on cycle day 1.

JS015

60 or 70 mg/m\^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.

Irinotecan Liposome Injection

2400mg/m\^2, intravenously, over 46 h on day 1, Q2W.

5-Fluorouracil (5-FU)

400mg/m\^2, intravenously, over 30 min on day 1, Q2W.

Leucovorin (LV)

125 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.

Nab paclitaxel

1000 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.

Xianjun Yu, M.D.

This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer.

The cohort A/B/C included patients with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy.The cohort D/E/F included patients with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer.This study plans to first explore A/B/C cohort, and then start the D/E/F cohort after determining the safety.

Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

If less than 2 participants developed DLT during the safety observation period (one cycle after the first dose), follow-up first-line D/E/F cohort exploration should be considered. Otherwise, it is up to the investigator to decide the next research plan.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.

ORR was defined as the percentage of participants with a best overall response of CR or PR based on RECIST 1.1.

DCR was defined as the percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable based on RECIST 1.1.

DOR will be calculated from the date of the first evaluation showing PR, or CR, to the date of the first disease progression or death, whichever comes first and based on RECIST 1.1.

PFS is defined as the time from the first dose until objective tumor progression(PD), or death, whichever comes first and based on RECIST 1.1. At the end of the study, the time of last acquisition of living patients without PD was taken as the deleted data.

OS will be measured from the date of first dose to death from any cause.

Adverse event (AE), abnormal laboratory examination, serious adverse event (SAE) related with the study drug judged using NCI-CTCAE V5.0 by investigator.

Fudan University

M.D.,Ph.D.

Pan He, Postgraduate

Yan Shi, PhD

This is an open label, phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS007 in the patients with advanced solid tumors who have progressed after standard of care, or lack of effective standard therapeutic regimen. This study is divided into two periods: dose escalation period, dose expansion period.

Clinical Study of JS007 in Patients With Advanced Solid Tumors

A Phase Ia Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single-dose and Multiple-dose Of JS007 Injection In Patients With Advanced Solid Tumors

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors), including objective response rate (ORR).

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including duration of response (DOR);

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including disease control rate (DCR);

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including progression-free survival (PFS)

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) , including overall survival (OS);

Expression of CTLA-4 in tumor tissues before administration

Expression of FoxP3 in tumor tissues before administration

Expression of IDO in tumor tissues before administration

mutation of immune related genes in tumor tissues before administration

expression of immune related genes in tumor tissues before administration

The maximum tolerated dose (MTD) is defined as the highest dose at which DLT （Dose-Limiting Toxicity）occurs in \<1/3 subjects

DLT is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 21 days after the first dose (NCI-CTCAE v5.0)

AE is assessed according to NCI-CTCAE 5.0

SAE（Serious adverse event） is assessed according to NCI-CTCAE 5.0

IrAE is assessed according to NCI-CTCAE 5.0

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-t )

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-inf);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; apparent volume of distribution(Vd)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss)

Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT)

The number of lymphocyte in peripheral blood before and after administration

The proportion of lymphocyte in peripheral blood before and after administration

concentration of neutralizing antibody (Nab)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment	NCT06370754	Pancreatic Canc...	JS001 JS004 JS007 JS015 Irinotecan Lipo... 5-Fluorouracil ... Leucovorin (LV) Nab paclitaxel Gemcitabine	18 Years - 75 Years	Fudan University
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment	NCT06370754	Pancreatic Canc...	JS001 JS004 JS007 JS015 Irinotecan Lipo... 5-Fluorouracil ... Leucovorin (LV) Nab paclitaxel Gemcitabine	18 Years - 75 Years	Fudan University
Clinical Study of JS007 in Patients With Advanced Solid Tumors	NCT05049265	Patients With A...	JS007	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for js007

Every month we try and update this database with for js007 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for js007

Every month we try and update this database with for js007 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for js007 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.