Actively Recruiting
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-04
70
Participants Needed
1
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with metastatic colorectal cancer, intrahepatic cholangiocarcinoma, or adrenocortical carcinoma with liver dominant disease
- Planning to receive or currently receiving standard chemotherapy appropriate for their cancer type
- Negative pregnancy test if of childbearing potential
- Agree to use highly effective contraception before, during, and after the study
- Agree to discontinue nursing if applicable
- Suitable arterial anatomy for hepatic artery infusion pump placement
- Able to sign informed consent
- HIV-positive participants must have undetectable viral load
- Agree to co-enroll in tumor tissue collection protocol
- Liver metastases not suitable for surgical removal or ablation in one stage
- For metastatic colorectal cancer: measurable liver metastases, received first-line chemotherapy, ECOG performance status 0-1, adequate organ and marrow function
- For intrahepatic cholangiocarcinoma: confirmed diagnosis confined to liver, measurable disease, unresectable, received first-line chemotherapy, ECOG 0-1, adequate organ and marrow function
- For adrenocortical carcinoma: confirmed diagnosis, received at least one line of chemotherapy, measurable liver metastases, ECOG 0-1, adequate organ and marrow function
You will not qualify if you...
- Currently receiving other investigational agents
- Prior treatment with recombinant IL-12
- Active autoimmune diseases except certain controlled conditions
- History of organ transplant requiring immunosuppression
- Active inflammatory bowel disease
- Allergies to study medications or similar compounds
- Significant active cardiovascular disease
- Conditions causing significant tissue necrosis outside tumor
- Recent esophageal or gastroduodenal ulcers
- Active ischemic bowel disease
- Psychiatric or social issues limiting study compliance
- Other active cancers within last 5 years except certain skin or thyroid cancers
- Prior radiation to liver
- Active hepatitis B or C infection
- Significant infections or positive tuberculosis history with symptoms
- Conditions risking participant safety or data interpretation
- For metastatic colorectal cancer: disease outside colon/rectum and liver (with exceptions for limited stable lung lesions), recent extra-hepatic metastasectomy with short disease-free interval, MSI-high status needing checkpoint inhibitors, prior FUDR treatment
- For intrahepatic cholangiocarcinoma: distant metastases (except resectable regional lymph nodes), prior FUDR treatment, sclerosing cholangitis, portal hypertension
- For adrenocortical carcinoma: extrahepatic abdominal disease not removable surgically, portal hypertension, sclerosing cholangitis, recent progressing lung metastases, untreated mismatch repair mutations needing checkpoint inhibitors
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Kathleen M Smith, R.N.
CONTACT
J
Jonathan M Hernandez, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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