Actively Recruiting
Safety of AM-928 Infusion in Advanced Solid Tumors
Led by AcadeMab Biomedical Inc. · Updated on 2026-04-28
38
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I, open-label, dose-escalation study for a novel cancer treatment, AM-928, intravenous infusion antibody for advanced solid tumor. The study is aimed to learn the safety, tolerability, pharmacokinetics, and preliminary efficacy profile of AM-928. The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. Seven dose levels are designed and each participant will be assigned to a specific dose regimen depending on the time of enrollment. In the study, each participant will receive AM-928 treatment cycles till meeting any treatment discontinuation criterion and be followed for safety and long-term survival. The whole study is expected to take approximately three years to complete.
CONDITIONS
Official Title
Safety of AM-928 Infusion in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with locally advanced unresectable or metastatic solid tumors not responding to standard therapy
- Availability of tumor tissue sample for EpCAM testing
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate blood, liver, kidney, and coagulation function as specified
- Female participants with childbearing potential must not be pregnant or breastfeeding
- Willing and able to follow study requirements and provide informed consent
You will not qualify if you...
- Recent cancer surgery or radiotherapy within 4 weeks before dosing, except certain palliative treatments
- Recent anti-cancer therapies within 2 weeks or 5 half-lives before dosing
- History of other primary cancers within 3 years except some treated skin or bladder cancers
- Recent use of immunosuppressive medications except specified low-dose steroids
- Significant heart or lung problems including uncontrolled hypertension, heart failure, myocarditis, or abnormal ECG
- Blood clots or stroke within 6 months before screening
- Prior treatment targeting EpCAM
- Active infections including recent tuberculosis, major infections, HIV, or hepatitis with high viral load
- Live vaccine use within 4 weeks before dosing
- Participation in another investigational drug study within 4 weeks
- Severe allergic reactions to humanized antibodies or components of AM-928
- Unstable brain tumors or metastases requiring steroids or chemotherapy
- Symptomatic fluid buildup in chest, heart, or abdomen
- Significant side effects from previous treatments that may interfere with safety
- Prior organ or stem cell transplant
- Medical or psychological conditions affecting study compliance or safety
- Requirement to use effective contraception during and after the study as specified
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
P
Pi-Chun Li, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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