Precision therapy platform for advanced pancreatic cancer

A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer

This trial tests antibody-drug conjugates (ADCs), given alone or with HRS-4642 or immunotherapy, to see if they are safe and can help control unresectable or metastatic pancreatic cancer in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06547736 on ClinicalTrials.gov

What this trial studies

This open-label, single-center Phase 2 platform enrolls adults with unresectable locally advanced or metastatic pancreatic cancer to receive ADC agents as monotherapy or combined with HRS-4642 or the PD-L1 antibody adebrelimab. The trial includes a dose-exploration stage to determine a recommended Phase 2 dose based on safety, tolerability, and early signs of activity, followed by an efficacy-exploration stage to evaluate tumor response and further safety. Key eligibility criteria include measurable disease by RECIST v1.1, ECOG 0–1, adequate organ and marrow function, and life expectancy of at least 12 weeks. All treatments and follow-up are conducted at Fudan University Shanghai Cancer Center.

Who should consider this trial

Good fit: Adults aged 18–75 with unresectable locally advanced or metastatic pancreatic cancer, ECOG 0–1, at least one measurable lesion, adequate organ function, and life expectancy ≥12 weeks who can attend Fudan Shanghai Cancer Center are ideal candidates.

Not a fit: Patients with ECOG >1, significant organ dysfunction, very limited life expectancy, or resectable disease are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the approach could provide a new targeted treatment option that improves tumor control or survival for some patients with advanced pancreatic cancer.

How similar studies have performed: ADCs and combinations with immunotherapy have shown benefit in several other cancers but remain largely experimental with limited proven success so far in pancreatic cancer.

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 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.

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, PHD

Conditions Pancreatic Cancer