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In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan

In Cohort 2, patients will be treated with JS015 in combination with paclitaxel

In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX

In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI

In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine

JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.

JS015

Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.

Toripalimab

Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.

Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.

Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.

Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.

Bevacizumab will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.

Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.

Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.

Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Jiangnian Liu, PM

Jin Li, MD

This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.

A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors

The highest plasma drug concentration that can be achieved after medication

The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration

The time it takes for the concentration of the drug in the plasma to be reduced by 50%

Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

The time from first dose to Disease progression or death

The time from first dose to death from any cause

Sponsor GmbH

Shanghai Junshi Bioscience Co., Ltd.

Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.

Kai Xu, Project manager

Lin Shen, Medical Doctor

Tongsen Zheng, Medical Doctor

Yuping Sun, Medical Doctor

Jin Li, Medical Doctor

Jinming Yu, Medical Doctor

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.

A Phase I Study Of JS015 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS015 In Patients With Advanced Solid Tumors

incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), Abnormal changes in laboratory and other tests with clinical significance

Maximum tolerated dose (MTD), Recommended dose for phase II trial

After a single dose, the time of peak blood concentration

the time it takes the blood to reduce the concentration of the drug to half

The time from randomization to death from any cause

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

Immunomodulating Agents

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors	NCT06139211	Advanced Solid ...	JS015 Toripalimab Paclitaxel Irinotecan Capecitabine Oxaliplatin Bevacizumab Fluorouracil Leucovorin Gemcitabine Albumin-Bound P...	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
A Phase I Study Of JS015 in Patients With Advanced Solid Tumors	NCT05770310	Advanced Solid ...	JS015	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
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

Spots Global Cancer Trial Database for js015

Every month we try and update this database with for js015 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 js015

Every month we try and update this database with for js015 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 js015 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.