Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Fibrolamellar Carcinoma (FLC) — a rare type of liver cancer — that has spread to other parts of the body or cannot be removed by surgery.
• People whose tumour tissue has tested positive for a specific genetic change called the DNAJB1-PRKACA fusion, confirmed by laboratory testing of stored tissue samples.
• People whose cancer has been shown on scans to have continued growing or spreading during or after immunotherapy treatment.
• People aged 12 years or older.
• Patients under 18 years old must weigh at least 40 kg (approximately 88 pounds).
• People whose general health and ability to carry out daily activities meets the study's fitness level requirements (confirm with trial site).
• People whose kidneys, liver, and other organs are functioning well enough to meet the study's laboratory test requirements (confirm with trial site).
• People who have at least one tumour or area of disease that can be measured on scans according to standard criteria.
• People who are willing to provide tissue and blood samples for research purposes as required by the study.
• Women who could become pregnant must have a negative pregnancy test before joining.
• Both men and women must agree to use an acceptable form of contraception for the duration of the study.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have received chemotherapy, biological cancer treatments, or radiation therapy within 21 days before the first study dose.
• People who have had surgery within 28 days before the first study dose (minor procedures may be an exception — confirm with trial site).
• People who have received other approved or experimental treatments or devices within 21 days before the first study dose.
• People who have not yet recovered from significant side effects of previous treatments (confirm with trial site for specific grade thresholds and exceptions).
• People with a specific type of heart rhythm abnormality involving a prolonged QT interval on an ECG (confirm with trial site).
• People currently taking certain medications that strongly affect how the body processes drugs — including apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, or St. John's Wort — if those medications cannot be stopped at least 14 days before starting the study.
• People with a known allergy or sensitivity to either of the two study drugs, DRP-104 or durvalumab, or to similar compounds.
• People with a lung condition called interstitial lung disease that causes symptoms or could interfere with monitoring of lung-related side effects.
• People whose blood oxygen level is below 92% when breathing normal room air, or who require supplemental oxygen at home.
• People with active or untreated cancer that has spread to the brain or the lining around the brain or spinal cord.
• People with uncontrolled medical or psychiatric conditions that would make it difficult to follow the study requirements.
• People with uncontrolled infections, serious heart conditions, or other uncontrolled illnesses that would interfere with participation.
• People who are pregnant or breastfeeding.
• People with a known history of HIV/AIDS.
• People with active Hepatitis B infection.
• People with active or recent diverticulitis, abdominal abscess, or bowel blockage, who may need additional treatment before being considered (confirm with trial site).
• People who are unwilling or unable to follow the study schedule.
• People who are currently using recreational or illicit drugs, or who have had a substance use or alcohol problem within the past year.
• People with a clinical sign of fluid build-up in the abdomen (ascites).
• People who have previously had severe or life-threatening reactions to a type of immunotherapy known as anti-PD-1 or anti-PD-L1 therapy.
• People with an active autoimmune disease that has required medical treatment within the past 2 years.
• People who have previously received a donor stem cell transplant or organ transplant.
• People with a diagnosed immune deficiency condition.
• People currently taking high-dose steroid medications that suppress the immune system.
• People who have received a live or attenuated (weakened) vaccine within 4 weeks before starting the study.
• People who have received allergy desensitisation therapy within 2 weeks before starting the study.

Important: Always verify eligibility with the trial site directly before applying.