HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Official title

An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Overview

To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Detailed description

This study is an open, single center, exploratory clinical trial aimed at evaluating the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel and Adebrelimab for neoadjuvant and adjuvant treatment of pancreatic cancer

Interventions

• Drug HRS-4642+AG +Adebrelimab
  HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned.

Primary outcome measures

• Adverse events (AEs) [Time frame: From the first drug administration to within 30 days for the last dose]
• Objective Response Rate (ORR) [Time frame: Up to approximately 6 months]

Secondary outcome measures (5)

• pathologic complete response (pCR) [Time frame: At the time of surgery]
• Overall survival (OS) [Time frame: Up to approximately 12 months]
• major pathologic response (MPR, CAP Score 0-1) [Time frame: At the time of surgery]
• Disease-free survival (DFS) [Time frame: Up to approximately 6 months]
• Event-free survival (EFS) [Time frame: Up to approximately 6 months]

Eligibility criteria

Inclusion criteria

• Age: ≥18 and ≤80 years old, male or female;
• Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
• Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Adequate marrow and organ function;
• Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;
• Patients volunteered to participate in this study and signed informed consent;

Exclusion criteria

• Previously received any anti-tumor therapy;
• the presence of distant metastatic lesions diagnosed by imaging;
• Known hypersensitivity to the study drug or any of its components;
• previous or concurrent other malignant tumors;
• Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
• Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
• previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
• Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
• with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
• with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \[HBsAg\] test result at screening together with an HBVDNA test value of ≥10,000 copies/ml \[2000 IU/ ml\]), active hepatitis C (hepatitis C virus antigen \[HCV-antibodies\] at screening), or active hepatitis C (hepatitis C virus antitoxin \[HCVantibodies\] at screening).antibody \[HCV-Ab\] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;
• Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and/or lipase are associated with pancreatic cancer);
• Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);
• Systemic treatment with corticosteroids (>10 mg/day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses

≤10 mg/day of prednisone efficacy permitted in the absence of active autoimmune disease

• Other situations that the researcher felt should not be included.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07131514 · PANC-PERI-IIT-HRS4642-AG-PD-L1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗