Guadecitabine + Durvalumab for Liver and Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byAnthony El-Khoueiry, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase Ib trial studies the side effects and best dose of guadecitabine and how well it works when given together with durvalumab in treating patients with liver, pancreatic, bile duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as durvalumab, may block tumor growth in different ways by targeting certain cells. Giving guadecitabine and durvalumab may work better in treating patients with liver, pancreatic, bile duct, or gallbladder cancer.

Eligibility Criteria

This trial is for adults with advanced liver, pancreatic, bile duct, or gallbladder cancer that has spread. Participants must be able to follow the study plan and have certain blood counts and organ functions within specific ranges. They should not be pregnant or breastfeeding and must use contraception. People who've had certain other treatments or conditions like inflammatory bowel disease, another primary malignancy within 3 years, uncontrolled brain metastases, or a history of severe immune-related side effects from previous immunotherapy are excluded.

Inclusion Criteria

My hemoglobin level is at least 8.0 g/dL, or it has been maintained at this level for over a week after a transfusion.

Your liver enzymes (AST and ALT) should not be more than 2.5 times the normal limit, unless you have liver metastases or chronic liver disease (hepatitis), in which case they should not be more than 5 times the normal limit.

My kidney function, measured by creatinine clearance, is good.

+14 more

Exclusion Criteria

You have a history of a weakened immune system from birth.

Patients may not be receiving any other investigational agents

Patients must not be nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

+21 more

Participant Groups

The trial is testing the combination of guadecitabine (which may block enzymes needed for tumor cell growth) with durvalumab (a monoclonal antibody targeting cancer cells). It aims to determine the best dose and assess how well these drugs work together against various types of advanced cancers when they have spread beyond their original location.

1Treatment groups

Experimental Treatment

Group I: Treatment (guadecitabine, durvalumab)Experimental Treatment2 Interventions

Patients receive guadecitabine SC QD on days 1-5 and durvalumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: