Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

NCT ID: NCT06370754

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)

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.

Group Type: EXPERIMENTAL

JS001

Intervention Type: DRUG

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

JS004

Intervention Type: DRUG

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

Irinotecan Liposome Injection

Intervention Type: DRUG

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

5-Fluorouracil (5-FU)

Intervention Type: DRUG

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

Leucovorin (LV)

Intervention Type: DRUG

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

Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV

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.

Group Type: EXPERIMENTAL

JS001

Intervention Type: DRUG

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

JS007

Intervention Type: DRUG

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

Irinotecan Liposome Injection

Intervention Type: DRUG

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

5-Fluorouracil (5-FU)

Intervention Type: DRUG

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

Leucovorin (LV)

Intervention Type: DRUG

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

Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV

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.

Group Type: EXPERIMENTAL

JS001

Intervention Type: DRUG

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

JS015

Intervention Type: DRUG

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

Irinotecan Liposome Injection

Intervention Type: DRUG

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

5-Fluorouracil (5-FU)

Intervention Type: DRUG

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

Leucovorin (LV)

Intervention Type: DRUG

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

Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine

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.

Group Type: EXPERIMENTAL

JS001

Intervention Type: DRUG

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

JS004

Intervention Type: DRUG

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

Nab paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine

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.

Group Type: EXPERIMENTAL

JS001

Intervention Type: DRUG

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

JS007

Intervention Type: DRUG

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

Nab paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine

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.

Group Type: EXPERIMENTAL

JS001

Intervention Type: DRUG

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

JS015

Intervention Type: DRUG

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

Nab paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Interventions

JS001

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

Intervention Type: DRUG

JS004

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

Intervention Type: DRUG

JS007

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

Intervention Type: DRUG

JS015

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

Intervention Type: DRUG

Irinotecan Liposome Injection

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

Intervention Type: DRUG

5-Fluorouracil (5-FU)

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

Intervention Type: DRUG

Leucovorin (LV)

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

Intervention Type: DRUG

Nab paclitaxel

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Other Intervention Names

Toripalimab

Eligibility Criteria

Inclusion Criteria

• Voluntary participation, written informed consent, complied well and cooperated with the follow-up visits;
• Age ≥ 18 years old, female or male individuals;
• Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1, the expected survival is more than 3 months;
• Patients with locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology or cytopathology (islet cell tumor is not eligible for inclusion) who meet the following requirements:

• For the A/B/C/ cohort: Had failed of at least first-line systemic therapy; disease recurrence or progression within 6 months of the last treatment of neoadjuvant or adjuvant chemotherapy was also allowed to be enrolled;
• For the D/E/F cohort: No prior systemic treatment; patients with recurrence or progression of disease more than 6 months after the last treatment of neoadjuvant or adjuvant chemotherapy were also allowed to be enrolled;
• Had at least one measurable lesion according to RECIST v1.1.
• Patients had adequate major organs function;
• Women of childbearing potential must undergo serum pregnancy test within 7 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.

Exclusion Criteria

• Previously received drugs with the same target as the planned investigational therapy;
• radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, immunotherapy, or molecular targeted therapy within 4 weeks prior to initial administration, except for bisphosphonates (which can be used for bone metastasis);
• Uncontrolled central nervous system metastases (meaning symptoms or the use of glucocorticoids or mannitol to control symptoms);
• A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia, in the 6 months prior to initial dosing;
• Patients with Grade 1 and above adverse reactions caused by previous treatment, including Grade 1 peripheral neurotoxicity; hair loss is not included and the investigator should clearly record the reasons;
• Malignant tumors within 5 years prior to the first dose (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
• Active autoimmune disease requiring systemic treatment within 2 years prior to first administration, except for vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy only;
• History of rapid allergic reaction, eczema or asthma that cannot be controlled by topical corticosteroids;
• Patients who have lung disease, such as drug-induced interstitial lung disease or pneumonia, obstructive pulmonary disease that severely affects lung function, and symptomatic bronchospasm;
• Serious infections requiring antibiotic treatment within 14 days prior to initial administration (>CTCAE grade 2), such as severe pneumonia, bacteremia, comorbidifications, etc., resulting in the need for hospitalization;
• Vaccination of live vaccine within 4 weeks before the first dose or during the study period;
• Known human immunodeficiency virus (HIV) infection, allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• History of prior allergy to any component or excipient of the investigational drug to be received;
• Other conditions assessed by the investigator as unsuitable for participation in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

M.D.,Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Xianjun Yu, M.D.

Role: CONTACT

yuxianjun@fudanpci.org

+86-18017317266

Other Identifiers

2401289-19-2403

Identifier Type: -

Identifier Source: org_study_id