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

Summary

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.

Timeline

Start

2022-10-24

Primary completion

2027-12-31

Completion

2028-12-31

Publications

• Friedman LR, Smith EC, Sarvestani AL, Eade AV, Ho J, Pu T, Larrain C, Hannah CE, Magee T, Smith KM, Satterwhite AA, Xiao S, Burke JF, Sinha S, Desai PP, Remmert K, Cavnar MJ, Gulley JL, Schlom J, Del Rivero J, Hernandez JM. Study protocol: targeted delivery of interleukin-12 in combination with hepatic artery infusion pump therapy for patients with adrenocortical carcinoma liver metastases. BMC Cancer. 2026 Jun 27. doi: 10.1186/s12885-026-16425-0. Online ahead of print.
• Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.
• Victory JH, Smith EC, Ryan CE, Lambdin J, Sarvestani AL, Friedman LR, Eade AV, Larrain C, Pu T, Luberice K, Ramamoorthy B, Rainey AJ, Hannah CE, Smith KM, Mabry D, Xie C, Davis JL, Blakely AM, Gulley JL, Schlom J, Monge C, Greten TF, Hernandez JM. Hepatic artery infusion pump (HAIP) therapy in combination with targeted delivery of IL-12 for patients with metastatic colorectal cancer or intrahepatic cholangiocarcinoma: a phase II trial protocol. J Gastrointest Oncol. 2024 Jun 30;15(3):1348-1354. doi: 10.21037/jgo-24-71. Epub 2024 Jun 20.

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Indications