New combo therapy targets hard-to-treat pancreatic cancer
NCT ID NCT06427239
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug (HRS-4642) combined with an immunotherapy (adebrelimab) and possibly other cancer drugs for people with advanced pancreatic cancer that has not responded to standard treatments. The goal is to find safe doses and see if the combination can shrink tumors or slow the disease. About 130 adults aged 18 to 75 will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Other studies related to the condition(s) this trial covers.
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- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors