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An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer

NCT06938282•Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: ≥18 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. Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition;
•4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
•5. Expected survival ≥ 6 months;
•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 3 months after the last study administration;
•8. Patients volunteered to participate in this study and signed informed consent.

Exclusion Criteria

•1. Previously received any systemic therapy, including systemic chemotherapy, immunotherapy, targeted therapy, and anti-tumor Chinese medicine;
•2. Known hypersensitivity to the study drug or any of its components;
•3. Previous or concurrent other malignant tumors;
•4. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
•5. Live and attenuated vaccines were administered within 4 weeks prior to the first dose of study drug;
•6. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
•7. Active CNS metastases (including CNS metastases with clinical symptoms, brain edema, CNS metastases that have been treated with or required steroid medications in the last 28 days, and CNS metastases that are new or have shown disease progression);
•8. Symptomatic, advanced patients with visceral dissemination and short-term risk of life-threatening complications (including patients with uncontrolled large amounts of exudate \[thoracic, pericardial, peritoneal\]); if effusion is drained, those who have been stable for at least 2 weeks after drainage are eligible for enrollment (topical plasmapheresis is permitted on a routine basis prior to signing an informed consent form);
•9. 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;
•10. Individuals 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);
+5 more criteria

Key Dates

Start Date

May 1, 2025

Primary Completion Date

April 30, 2027

Completion Date

April 30, 2029

Last Updated

April 25, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

HRS-4642

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients