Clinical trial NCT06427239: Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
Official title: A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2024-05-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Dose Limited Toxicity (DLT)
timeFrame: Day 1 to Day 21 after the first combination therapy was administrated
measure: Recommended phase II dose (RP2D)
timeFrame: Approximately 12 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 12 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 12 months
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 12 months
measure: Overall survival (OS)
timeFrame: Up to approximately 12 months
measure: Adverse events (AEs)
timeFrame: From the first drug administration to within 90 days for the last adebrelimab dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Shanghai
Study officials:
References: