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Clinical Trial Record

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Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

2024-05-29

2026-06

2026-09

35

Study Overview

Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebelimab in subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma.

This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebelimab in the treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of HRS-4642 combined with adelbizumab treatment, and then entered the efficacy exploration phase.

  • Pancreatic Cancer
  • DRUG: HRS-4642
  • DRUG: Adebrelimab
  • PANC-2nd-IIT-HRS4642-SHR1316

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-05-19  

N/A  

2024-08-07  

2024-05-19  

N/A  

2024-08-09  

2024-05-23  

N/A  

2024-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dose Escalation 300mg

For HRS-4642 in combination with Adebrelimab, for advanced or metastatic pancreatic ductal adenocarcinoma.

DRUG: HRS-4642

  • HRS-4642 will be administrated per dose level in which the patients are assigned.

DRUG: Adebrelimab

  • Adebrelimab will be administrated per dose level in which the patients are assigned
EXPERIMENTAL: Dose Escalation 400mg

For HRS-4642 in combination with Adebrelimab, for advanced or metastatic pancreatic ductal adenocarcinoma.

DRUG: HRS-4642

  • HRS-4642 will be administrated per dose level in which the patients are assigned.

DRUG: Adebrelimab

  • Adebrelimab will be administrated per dose level in which the patients are assigned
EXPERIMENTAL: Dose Escalation 500mg

For HRS-4642 in combination with Adebrelimab, for advanced or metastatic pancreatic ductal adenocarcinoma.

DRUG: HRS-4642

  • HRS-4642 will be administrated per dose level in which the patients are assigned.

DRUG: Adebrelimab

  • Adebrelimab will be administrated per dose level in which the patients are assigned
Primary Outcome MeasuresMeasure DescriptionTime Frame
Dose Limited Toxicity (DLT)A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illnessDay 1 to Day 21 after the first combination therapy was administrated
Recommended phase II dose (RP2D)RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.Approximately 12 months
Objective Response Rate (ORR)Evaluated by RECIST v1.1.Up to approximately 12 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease Control Rate (DCR)Evaluated by RECIST v1.1.Up to approximately 12 months
Duration of Response (DOR)Evaluated by RECIST v1.1.Up to approximately 12 months
Progression Free Survival (PFS)Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.Up to approximately 12 months
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
Adverse events (AEs)AEs are assessed by NCI-CTCAE v5.0From the first drug administration to within 90 days for the last adebrelimab dose

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Si Shi

Phone Number: +86-021-64179375

Email: Shisi@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Patients volunteered to participate in this study and signed informed consent; 2. Age: ≥18 and ≤75 years old, male or female; 3. Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1; 4. With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 6. Life expectancy ≥ 12 weeks; 7. Adequate marrow and organ function; 8. AE caused by previous anti-tumor therapy must be restored to ≤ level 1 (CTCAE v5.0) or a stable state evaluated by the researcher, except for hair loss (any level) and peripheral neuropathy of level 2; 9. 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;
    Exclusion Criteria:
    1. Known to be allergic to the investigational drug or any of its components; 2. Have other active malignancies within 5 years; 3. Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose; 4. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation; 5. Accompanied by untreated or active central nervous system (CNS) metastases; 6. Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism; 7. Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg); 8. Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term; 9. With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects); 10. Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration; 11. With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection; 12. With any active autoimmune diseases or a history of autoimmune diseases; 13. Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication; 14. High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN; who have a simple increase in lipase, will be considered for inclusion by the researchers; 15. Other situations that researchers believe should not be included.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Jiangsu HengRui Medicine Co., Ltd.
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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