Study of PDS01ADC with HAIP and Systemic Therapy for Advanced Cancers
This study is testing a new approach for people with metastatic colorectal cancer, intrahepatic cholangiocarcinoma (a type of bile duct cancer), or metastatic adrenocortical carcinoma (a type of adrenal gland cancer) that has spread to the liver. It combines a special pump called a Hepatic Artery Infusion Pump (HAIP) to deliver chemotherapy (Floxuridine and Dexamethasone) directly to the liver, along with a drug called PDS01ADC. PDS01ADC is designed to help your immune system fight the cancer. Researchers want to see how many people respond to this combination treatment. You may be eligible if you are 18 or older and have one of these cancers with liver involvement, and are already receiving or planning to receive standard chemotherapy.
- Study design
- This is an interventional study planning to enroll 70 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive Dexamethasone and Floxuridine through the HAIP on Day 1 of each cycle, and PDS01ADC as a subcutaneous injection on Day 15 of each cycle. Your response will be measured at baseline, every 8 weeks while on treatment, and 4-8 weeks after initial response, with an additional scan at Week 12.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response will be monitored every 8 weeks while on treatment, and for 4-8 weeks after your initial response is documented.
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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
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~70 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:DexamethasonePDS01ADCIntera 3000 Hepatic Artery Infusion Pump (HAIP)Floxuridine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine overall response rates
Measured over baseline, every 8 weeks while on treatment, and 4-8 weeks following initial documentation of objective response; an additional scan is performed at Week 12.
Conditions
NCT05286814
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jonathan M Hernandez, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Eligibility criteria
Inclusion
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
Age \>= 18 years.
Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).
All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.
Nursing (including breastfeeding) participants must agree to discontinue nursing.
Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C/A/P multiphase) amenable to placement of the HAIP.
Participant must sign the informed consent form to participate in this study.
HIV-positive participants may be considered for this study only if they have an undetectable viral load.
Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, "Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors".
Participant's liver metastases must not be amenable to resection/ablation to No Evidence of Disease (NED) in one stage.
Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).
Participants must have measurable liver metastatic disease.
Participants must have received 1st line systemic chemotherapy.
ECOG performance status \<= 1.
Participants must have adequate organ and marrow function as defined below:
leukocytes \> 3,000/mcL
absolute neutrophil count \> 1,500/mcL
platelets \> 90,000/mcL
hemoglobin \> 8 g/dL
total bilirubin \< 1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal
creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \> 60 mL/min/1.73 m2.
Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.
Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.
Participants must have radiographically measurable disease.
Disease must be considered unresectable at the time of preoperative evaluation.
Participants must have received 1st line systemic chemotherapy.
ECOG performance status \<=1.
Participants must have adequate organ and marrow function as defined below:
leukocytes \>= 2,000/ mm\^3
absolute neutrophil count \> 1,500/mcL
platelets \>= 75,000/ mm\^3
hemoglobin \> 8 g/dL
total bilirubin \< 1.5 mg/dl
creatinine \<= 1.5 mg/dl
Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as "adrenocortical cancer".
Participants must have received at least one line of systemic chemotherapy.
Participants must have measurable liver metastatic disease.
ECOG performance status \<= 1.
Participants must have adequate organ and marrow function as defined below:
leukocytes \> 3,000/mcL
absolute neutrophil count \> 1,500/mcL
platelets \> 90,000/mcL
hemoglobin \> 8 g/dL
total bilirubin \< 1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) \< 3 X institutional upper limit of normal
creatinine \< 2 X institutional upper limit of normal
Exclusion
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.
Participants with incontrovertible radiographic evidence of disease outside of the colon/rectum (primary) and liver given unlikelihood of 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.
Prior treatment with FUDR.
Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
Prior treatment with FUDR.
Diagnosis of sclerosing cholangitis.
Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).
Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.
Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).
Diagnosis of sclerosing cholangitis.
Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.
Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.
What this trial measures
- Determine overall response ratesbaseline, every 8 weeks while on treatment, and 4-8 weeks following initial documentation of objective response; an additional scan is performed at Week 12.
Simon optimal two-stage Phase II trial design will be used to determine overall response using RECIST criteria. The clinical response rate (CR+PR) will be determined and reported along with a 95% confidence interval, separately by cohort.