Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
FD-IMPACT
A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
1 other identifier
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pancreatic-cancer
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedStudy Start
First participant enrolled
April 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
ExpectedApril 17, 2024
April 1, 2024
2 years
April 15, 2024
April 16, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of dose-limiting toxicity (DLT) (phase IB)
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.
21 days after the first dose was administered to each subject
Objective Response Rate (ORR) (phase II)
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.
Up to 1 year
Secondary Outcomes (6)
Objective Response Rate (ORR) (phase IB)
Up to 1 year
Disease control rate (DCR)
Up to 1 year
Duration of Response (DOR)
Up to 1 year
Progression free survival (PFS)
Up to 2 years
Overall Survival (OS)
Up to 2 years
- +1 more secondary outcomes
Study Arms (6)
Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)
EXPERIMENTALParticipants 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.
Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV
EXPERIMENTALParticipants 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.
Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV
EXPERIMENTALParticipants 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.
Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine
EXPERIMENTALParticipants 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.
Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine
EXPERIMENTALParticipants 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.
Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine
EXPERIMENTALParticipants 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.
Interventions
240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.
200 mg by IV infusion Q3W, given on cycle day 1.
3mg/kg by IV infusion Q3W, given on cycle day 1.
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.
2400mg/m\^2, intravenously, over 46 h on day 1, Q2W.
400mg/m\^2, intravenously, over 30 min on day 1, Q2W.
125 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.
1000 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.,Ph.D.
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 17, 2024
Study Start
April 30, 2024
Primary Completion
April 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
April 17, 2024
Record last verified: 2024-04