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Trial Title:
Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
NCT ID:
NCT06427239
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4642
Description:
HRS-4642 will be administrated per dose level in which the patients are assigned.
Arm group label:
Dose Escalation 300mg
Arm group label:
Dose Escalation 400mg
Arm group label:
Dose Escalation 500mg
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab will be administrated per dose level in which the patients are assigned
Arm group label:
Dose Escalation 300mg
Arm group label:
Dose Escalation 400mg
Arm group label:
Dose Escalation 500mg
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
XianJun Yu, M.D., Ph.D.
Phone:
+86-21-6417-5590
Email:
yuxianjun@fudanpci.org
Investigator:
Last name:
Xianjun Yu, M.D., Ph.D.
Email:
Principal Investigator
Start date:
May 29, 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06427239
