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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAcepodia Biotech, Inc.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • ACE723

    Drug

    Intravenous Administration

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: ACE723Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Up to 12 months post-last dose
2

Part 1: To determine the maximum tolerated dose (MTD) of ACE723

Time frame
Up to 12 months post-last dose
3

Part 1: To determine the recommended ACE723 doses for further evaluation in the dose expansion phase

Time frame
Up to 12 months post-last dose
4

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)

Time frame
Up to 12 months post-last dose

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: