Phase 1 Trial of ACE723, A Dual-Payload Antibody Drug Conjugate, in Patients With Advanced HCC Who Have Failed or Progressed on Standard Systemic Therapy Containing ICIs

Inclusion Criteria:

• Males or females aged 18 to 75 years
• HCC that is unresectable or metastatic
• Pathologically confirmed HCC
• Barcelona Clinic Liver Cancer (BCLC) stage B or C
• Presence of at least 1 measurable lesion per RECIST 1.1
• ECOG Performance Score of 0 or 1
• Life expectancy of at least 3 months for the dose escalation portion and of at least 6 months for the dose expansion portion
• Adequate bone marrow reserve
• Adequate renal function
• Adequate hepatic function
• Left ventricular ejection fraction (LVEF) ≥50%
• Ability to fully understand the investigational nature of this study
• Agreement to contraception requirements

Exclusion Criteria:

• Other types of hepatic malignancies, such as mixed cholangiocarcinoma/HCC, sarcomatoid HCC, or fibrolamellar HCC,
• History of another malignancy within the past 5 years
• Ascites that requires non-pharmacologic intervention (e.g., paracentesis)
• History of hepatic encephalopathy within 12 months
• History of (non-infectious) ILD/pneumonitis
• History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or known sensitivity or allergy to any components of ACE723.
• History of bleeding events (including hematemesis or melena)
• Active CNS metastases
• Unresolved toxicities from prior anticancer therapy
• Clinically significant active infection
• Active syphilis infection and HIV infection
• Pregnancy or breast-feeding women
• Uncontrolled intercurrent illness
• History of known substance abuse or illicit drug use
• Poor compliance