HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

NCT06587061 | Recruiting Phase 2

• 1 other identifier: PANC-PERI-IIT-HRS4642-AG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  AEs are assessed by NCI-CTCAE v5.0

  From the first drug administration to within 30 days for the last dose

• Objective Response Rate (ORR)

  Evaluated by RECIST v1.1

  Up to approximately 6 months

Secondary Outcomes (7)

• Total resection rate

  At the time of surgery

• pathologic complete response (pCR)

  At the time of surgery

• R0 resection rate

  At the time of surgery

• major pathologic response (MPR, CAP Score 0-1)

  At the time of surgery

• Disease-free survival (DFS)

  Up to approximately 6 months

Other Outcomes (1)

• CA19-9 response rate

  Up to approximately 6 months

Study Arms (1)

HRS-4642, Gemcitabine and Albumin-bound Paclitaxel

EXPERIMENTAL

HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Drug: HRS-4642+AG

Interventions

HRS-4642+AG DRUG

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

HRS-4642, Gemcitabine and Albumin-bound Paclitaxel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 \[HCV-antibodies\] 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);
• Other situations that the researcher felt should not be included.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

CN (1)