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

HAIP FUDR and Dexamethasone treatment on D1 of every cycle. Floxuridine: (0.12 mg/kg x ideal average body weight in kg X 30 mL \[pump volume\] / Pump Flow Rate)

IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: will receive either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan). FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) IV infusion administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5FU (2000 mg/m2) administered via an ambulatory device on site. FOLFIRI: irinotecan (150 mg/m2) and leucovorin (400 mg/m2) IV infusion administered concurrently via Y-Line over 30 minutes, then a 46-hour infusion of 5FU (2000 mg/m2) administered via an ambulatory device on site.

IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: will receive either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFIRI: irinotecan (150 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 30 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site.

Intera 3000 HAIP will be filled with mixture of Floxuridine and Dexamethasone in 25,000 units heparin/saline (Heparin + 0.9% Sodium Chloride) on Day 1; Days 1-14 of every cycle pump will perfuse drugs to liver. On Day 15 of each cycle, the pump will be emptied and filled with 30,000 units heparin/saline (Heparin + 0.9% Sodium Chloride); Days 15-28 of every cycle will perfuse heparin/saline to liver.

IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site. Arm 2: GemOx (gemcitabine \[800 mg/m2 IV over 30 minutes\] and oxaliplatin \[85 mg/ m2 IV over 120 minutes\])

IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: will receive either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site. FOLFIRI: irinotecan (150 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 30 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site.

PDS01ADC will be administered by subcutaneous injection on Day 15 of every cycle. Cycle 1 at 12 mcg/kg; Cycle 2 reduced to 8 mcg/kg with the addition of systemic chemotherapy, to continue for further cycles. Note: any dose reduction in FUDR = 50% due to liver enzyme elevations means that the dose of PDS01ADC will be reduced to 4 mcg/kg.

IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 2: GemOx (gemcitabine \[800 mg/m2 IV over 30 minutes\] and oxaliplatin \[85 mg/ m2 IV over 120 minutes\])

HAIP FUDR and Dexamethasone treatment on D1 of every cycle. Dexamethasone: (1 mg/day X pump volume / pump flow rate)