OncoMatch/Clinical Trials/NCT05286814
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Is NCT05286814 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dexamethasone and PDS01ADC for metastatic colorectal cancer (mcrc).
Treatment: Dexamethasone · PDS01ADC · Intera 3000 Hepatic Artery Infusion Pump (HAIP) · Floxuridine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Cholangiocarcinoma
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy — first line
Participants must have received 1st line systemic chemotherapy
Must have received: systemic chemotherapy — at least one line
Participants must have received at least one line of systemic chemotherapy (ACC cohort)
Cannot have received: rIL-12
Participants who have previously received rIL-12
Cannot have received: FUDR
Prior treatment with FUDR
Cannot have received: radiation therapy
Exception: Prior radiation to liver
Prior radiation to liver
Lab requirements
Blood counts
leukocytes > 3,000/mcL (mCRC, ACC)absolute neutrophil count > 1,500/mcL (mCRC, ACC, ICC)platelets > 90,000/mcL (mCRC, ACC)hemoglobin > 8 g/dL (mCRC, ACC, ICC)leukocytes >= 2,000/ mm^3 (ICC)platelets >= 75,000/ mm^3 (ICC)
Kidney function
creatinine within normal institutional limits OR eGFR > 60 mL/min/1.73 m2 (mCRC)creatinine <= 1.5 mg/dl (ICC)creatinine < 2 X institutional upper limit of normal (ACC)
Liver function
total bilirubin < 1.5 X institutional upper limit of normal (mCRC, ACC)AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal (mCRC)AST(SGOT)/ALT(SGPT) < 3 X institutional upper limit of normal (ACC)total bilirubin < 1.5 mg/dl (ICC)creatinine within normal institutional limits OR eGFR > 60 mL/min/1.73 m2 (mCRC)creatinine <= 1.5 mg/dl (ICC)creatinine < 2 X institutional upper limit of normal (ACC)
Participants must have adequate organ and marrow function as defined below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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