About this trial
ACE723 is a dual-payload antibody drug conjugate targeting glypican-3 (GPC-3) that is under investigation for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
ACE723
DrugIntravenous Administration
Treatment groups
Trial outcomes
Primary outcomes
Part 1: To assess the safety and tolerability of ACE723 administered at multiple ascending doses
* Incidence of dose-limiting toxicities (DLTs) during the DLT evaluation period * Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Part 1: To determine the maximum tolerated dose (MTD) of ACE723
Part 1: To determine the recommended ACE723 doses for further evaluation in the dose expansion phase
Part 2: To assess the safety and tolerability of ACE723 at the expansion doses
• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: