NCT07861425Not yet recruitingPhase 1
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 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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- May 2030
- Lead sponsor
- Acepodia Biotech, Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07861425
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 70
- From Nov 2026 to the primary completion date, May 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unresolved toxicities from prior anticancer therapy
Other illness
- Other types of hepatic malignancies, such as mixed cholangiocarcinoma/HCC, sarcomatoid HCC, or fibrolamellar HCC,
- History of another malignancy within the past 5 years
- 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)
- Clinically significant active infection
- Active syphilis infection and HIV infection
- Uncontrolled intercurrent illness
- History of known substance abuse or illicit drug use
Other
- Ascites that requires non-pharmacologic intervention (e.g., paracentesis)
- Active CNS metastases
- Pregnancy or breast-feeding women
- Poor compliance
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Tianyinshan Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.