Study on BXCL701 and Pembrolizumab for Patients with Metastatic Pancreatic Cancer

Inclusion Criteria

• Have a confirmed diagnosis of pancreatic ductal adenocarcinoma that has spread to other parts of the body.
• Agree to have two biopsies and have tumors that can be biopsied multiple times.
• Have measurable cancer based on specific imaging criteria.
• Cancer must have worsened or not responded to at least one previous treatment for metastatic disease.
• Be in good general health with an ECOG performance status of 0 to 2.
• Be 18 years or older.
• No active brain metastases or have treated brain metastases that are stable.
• Have a normal heart rhythm as shown by an ECG.
• Have adequate bone marrow, kidney, and liver function based on blood tests.
• Have recovered from any previous surgeries.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception.
• Be able to swallow pills whole.
• Understand and agree to the study requirements and sign informed consent.
• Have resolved any side effects from previous cancer treatments to a mild level, except for certain nerve damage or hair loss.
• Male patients and their female partners must agree to use effective contraception during the study and for six months after the last dose.

Exclusion Criteria

• Have previously received certain types of cancer treatments, including FAP inhibitors, DPP inhibitors, or specific immune therapies.
• Have had any cancer treatment within two weeks before starting the study.
• Have any severe or uncontrolled medical conditions that could pose safety risks or interfere with the study.
• Be pregnant or breastfeeding.
• Have psychiatric or social issues that could affect study participation.
• Have another active cancer or a history of cancer within the last two years, except for certain skin or cervical cancers.
• Have untreated or unstable brain metastases.
• Have digestive issues that could affect the absorption of the study drugs.
• Have a history of HIV or active hepatitis B or C infections.
• Have uncontrolled lung or heart diseases.
• Have received a live vaccine within 30 days before starting the study.
• Have an active autoimmune disease requiring treatment in the past two years.
• Require systemic treatment with steroids or other immunosuppressive drugs within 14 days before starting the study.
• Be a prisoner.