Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

Sponsor
Fudan University
Study ID
NCT06370754
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JS001 — DRUG
    240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.
  • JS004 — DRUG
    200 mg by IV infusion Q3W, given on cycle day 1.
  • JS007 — DRUG
    3mg/kg by IV infusion Q3W, given on cycle day 1.
  • JS015 — DRUG
    600mg by IV infusion Q3W, given on cycle day 1.
  • Irinotecan Liposome Injection — DRUG
    60 or 70 mg/m\^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.
  • 5-Fluorouracil (5-FU) — DRUG
    2400mg/m\^2, intravenously, over 46 h on day 1, Q2W.
  • Leucovorin (LV) — DRUG
    400mg/m\^2, intravenously, over 30 min on day 1, Q2W.
  • Nab paclitaxel — DRUG
    125 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.
  • Gemcitabine — DRUG
    1000 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Apr 2024
Primary completion
Apr 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
117 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT) (phase IB) [ Time Frame: 21 days after the first dose was administered to each subject ]

Central Contacts

Related Studies