PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

Recruiting now · Phase 2

Conditions studied: Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc), Intrahepatic Bile Duct Cancer, Colorectal Neoplasms, Colorectal Cancer, Cholangiocarcinoma, Bile Duct Neoplasms, Bile Duct Cancer, Adrenocortical Carcinoma (ACC), Adrenal Cortical Carcinoma, Adrenal Gland Cancer, Adrenal Gland Neoplasms, Adrenal Cortex Neoplasms

In brief

Background: One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\<TAB\> Objective: To see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers. Eligibility: People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed) Tumor biopsy (if needed) Electrocardiogram Computed tomography (CT) scans Participants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen. All participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects. Participants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks. Participants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests. Participants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.

Key facts

Study ID

NCT05286814

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2022-10-24

Expected to finish

2028-12-31

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Exclusion Criteria- All Cohorts
• Participants who are receiving any other investigational agents.
• Participants who have previously received rIL-12.
• Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:
• diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
• participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses <= 10 mg of prednisone or equivalent per day;
• administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.
• History of organ transplant, except for transplants that do not require immunosuppression.
• History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).
• Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke < 6 months prior to enrollment, myocardial infarction < 6 months prior to enrollment, unstable angina, congestive heart failure (>= NYHA III) or serious cardiac arrhythmia requiring medication.
• All conditions associated with significant necrosis of nontumor-bearing tissues.
• Esophageal or gastroduodenal ulcers < 6 months prior to treatment.
• Active ischemic bowel disease.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.
• Prior radiation to liver.
• Participants with active Hepatitis B or C infection.
• Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).
• Any condition, including the presence of laboratory abnormalities and/or insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.
• Exclusion Criteria-Metastatic Colorectal Carcinoma
• Participants with incontrovertible radiographic evidence of disease outside of the colon/rectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.
• Note: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.
• Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.
• Participants with a history of MSI-high results who need to be treated with check-point inhibitors.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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