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

October 5, 2026 updated by: Acepodia Biotech, Inc.

A Phase 1 Clinical Trial of ACE723, A Dual-Payload Antibody Drug Conjugate Targeting Glypican-3 (GPC-3), in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Who Have Failed or Progressed on Standard Immune Checkpoint Inhibitor-Containing Systemic Therapies

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Nanjing, China
        • Nanjing Tianyinshan Hospital
      • Shanghai, China
        • Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACE723
Drug: ACE723

Intravenous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: To assess the safety and tolerability of ACE723 administered at multiple ascending doses
Time Frame: Up to 12 months post-last dose
  • Incidence of dose-limiting toxicities (DLTs) during the DLT evaluation period
  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to 12 months post-last dose
Part 1: To determine the maximum tolerated dose (MTD) of ACE723
Time Frame: Up to 12 months post-last dose
Up to 12 months post-last dose
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
Up to 12 months post-last dose
Part 2: To assess the safety and tolerability of ACE723 at the expansion doses
Time Frame: Up to 12 months post-last dose

• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to 12 months post-last dose
Part 2: To determine the Recommended Phase 2 Dose (RP2D) of ACE723 for further clinical evaluation
Time Frame: Up to 12 months post-last dose
Up to 12 months post-last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acepodia Biotech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

September 29, 2026

First Submitted That Met QC Criteria

October 5, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 5, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE723-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe