PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Eligible age
18–120 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: National Cancer Institute (NCI)
You may qualify if…
- ✓ Participants must have a documented diagnosis of one of the following cancers:
- ✓ Metastatic colorectal cancer (mCRC)
- ✓ Intrahepatic cholangiocarcinoma (ICC)
- ✓ Adrenocortical carcinoma (ACC) with liver dominant disease
- ✓ Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:
- ✓ mCRC: FOLFOX or FOLFIRI
- ✓ ICC: GemOx or FOLFOX
- ✓ ACC: GemOx
You may not qualify if…
- ✕ 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).
Where it's recruiting
Bethesda
Source: ClinicalTrials.gov · NCT05286814 · last updated 2026-09-02