Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
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 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.
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. Participants will have 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 get systemic chemotherapy through an IV or mediport every 2 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects. Participants will have 2 study visits 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.
• Age \>= 18 years.
• Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).
∙ NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.
• 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.
• Participant must be able to tolerate systemic chemotherapy at initiation of study treatment as outlined below (mCRC: FOLFOX or FOLFIRI; ICC: GemOx or FOLFOX; ACC: GemOx).
• 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