NCT06427239 Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
| NCT ID | NCT06427239 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fudan University |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2024-06-17 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06427239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06427239 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06427239 currently recruiting?
Yes, NCT06427239 is actively recruiting participants. Contact the research team at Shisi@fudanpci.org for enrollment information.
Where is the NCT06427239 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06427239 clinical trial?
NCT06427239 is sponsored by Fudan University. The trial plans to enroll 130 participants.
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