Overview

The study is being conducted to evaluate the safety, tolerability and efficacy of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in subjects with locally advanced or metastatic pancreatic cancer.

Eligibility

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 cancer; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
5. Life expectancy ≥ 12 weeks;
6. Adequate marrow and organ function;
7. 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 6 months after the last study administration;

Exclusion Criteria:

1. Known to be allergic to the investigational drug or any of its components;
2. 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;
3. Have other active malignancies within 5 years;
4. Accompanied by untreated or active central nervous system (CNS) metastases;
5. Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria;
6. 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);
7. With gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 6 months before the start of treatment, but if surgical treatment has been performed and the obstruction is completely relieved, screening can be conducted;
8. Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
9. With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (defined as hepatitis B virus surface antigen \[HBsAg\] in screening period is positive and HBV-DNA detection value ≥ 10000 copies/ml \[2000 IU/ml\] or active hepatitis C (defined as hepatitis C virus antibody \[HCV Ab\] in screening period is positive and HCV RNA is positive);
10. With active pulmonary tuberculosis infection within one year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
11. Participated in other clinical studies or whose first medication is less than 4 weeks after the end of the previous clinical study (last medication), or whose study drug has a half-life of 5, whichever is shorter;
12. High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN, will be evaluated by the researchers;
13. Uncontrollable mental illnesses and other known factors that affect the completion of research procedures, such as alcohol, drug or substance abuse, criminal detention, etc;
14. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; Experiencing traumatic minor surgery (biopsy, endoscopic examination, and drainage surgery) within 7 days prior to the first administration;
15. Other situations that researchers believe should not be included.