Hepatocellular Carcinoma (HCC)Phase 1NCT07861425
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
A Phase 1 study testing ACE723 in people with Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma Metastatic, run by Acepodia Biotech, Inc. at 2 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Metastatic, Hepatocellular Carcinoma Non-Resectable
- What is being tested?
- ACE723
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to May 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Nanjing Tianyinshan Hospital
Nanjing
Zhongshan Hospital, Fudan University
Shanghai
About this study
Official title: 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).
- Conditions
- Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Metastatic, Hepatocellular Carcinoma Non-Resectable
- Being tested
- ACE723
- Keywords
- ACE723, Antibody Drug Conjugate, ADC, Hepatocellular Carcinoma, HCC, Glypican-3, GPC-3
- Medical subject headings
- Carcinoma, Hepatocellular, Simpson-Golabi-Behmel syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE723Drug
Intravenous Administration
| Study group | Role | What they receive |
|---|---|---|
| ACE723 | Experimental | Not described Receives: Drug: ACE723 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 12 months post-last dose
Part 1: To determine the maximum tolerated dose (MTD) of ACE723
Measured: Up to 12 months post-last dose
Part 1: To determine the recommended ACE723 doses for further evaluation in the dose expansion phase
Measured: Up to 12 months post-last dose
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)
Measured: Up to 12 months post-last dose
Part 2: To determine the Recommended Phase 2 Dose (RP2D) of ACE723 for further clinical evaluation
Measured: Up to 12 months post-last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acepodia Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861425
- Sponsor's protocol ID
- ACE723-001
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No