Combining HRS-4642 and Adebelimab for Advanced Pancreatic Cancer Treatment

A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

This study is testing a new combination of two drugs, HRS-4642 and adebelimab, to see if they can help people with advanced pancreatic cancer who haven't responded to other treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: adebelimab, adelbizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06427239 on ClinicalTrials.gov

What this trial studies

This exploratory clinical trial aims to evaluate the safety, tolerability, and efficacy of HRS-4642 combined with adebelimab in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma. The study is divided into two stages: a dose exploration phase to determine the recommended phase 2 dose (RP2D) based on safety and preliminary efficacy data, followed by an efficacy exploration phase. The trial is conducted at a single center, focusing on patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced pancreatic ductal adenocarcinoma who have measurable lesions and have failed standard treatments.

Not a fit: Patients with resectable pancreatic cancer or those who have not progressed after standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced pancreatic cancer.

How similar studies have performed: While this approach is exploratory, similar combinations in other studies have shown promise, indicating potential for success.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Si Shi

Conditions: Pancreatic Cancer