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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: HRS-4642+AG

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 for neoadjuvant and adjuvant treatment of pancreatic cancer

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Ruijin Hospital Shanghai Jiaotong University School of Medicine
      • Principal Investigator: Baiyong Shen, Ph.D&M.D
      • Contact: Baiyong Shen, Ph.D&M.D; Phone Number: 0086-021-64370045; Email: shenby@shsmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: ≥18 and ≤80 years old, male or female;
2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
5. Life expectancy ≥ 12 weeks;
6. Adequate marrow and organ function;
7. 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;
8. Patients volunteered to participate in this study and signed informed consent;

Exclusion Criteria:

1. Previously received any anti-tumor therapy;
2. the presence of distant metastatic lesions diagnosed by imaging;
3. Known hypersensitivity to the study drug or any of its components;
4. previous or concurrent other malignant tumors;
5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
8. 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;
9. 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);
10. 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;
11. 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);
12. Other situations that the researcher felt should not be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-4642, Gemcitabine and Albumin-bound Paclitaxel; HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer	Drug: HRS-4642+AG; HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel will be administrated per dose level in which the patients are assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.	Up to approximately 12 months
major pathologic response (MPR, CAP Score 0-1)	Number of Subjects Achieving MPR as a Percentage of Subjects	At the time of surgery
Total resection rate	Percentage of subjects who received surgical treatment as a proportion of all subjects	At the time of surgery
pathologic complete response (pCR)	Number of subjects achieving pCR as a percentage of subjects	At the time of surgery
R0 resection rate	Number of Subjects Achieving R0 Removal as a Percentage of Subjects	At the time of surgery
Event-free survival (EFS)	The time from the first dose of neoadjuvant therapy to the occurrence of any event; events include the occurrence of imaging disease progression (based on the date of the imaging test), the occurrence of disease recurrence (local recurrence or distant recurrence) after surgery, and death from any cause, based on the time of the first occurrence	Up to approximately 6 months
Disease-free survival (DFS)	For subjects who achieved R0/R1 resection, the time from the start of surgery to disease recurrence (local or distant) or death from any cause, whichever occurs first	Up to approximately 6 months

Other Outcome Measures

Outcome Measure	Time Frame
CA19-9 response rate	Up to approximately 6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PANC-PERI-IIT-HRS4642-AG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No