Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141
Led by Ascendo Biotechnology Co., Ltd. · Updated on 2026-01-07
21
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has voluntarily agreed to participate by giving written informed consent.
- Male or female aged 18 years or older at consent.
- Histologically or cytologically confirmed metastatic solid tumor with no effective therapy available.
- At least one measurable lesion by RECIST v1.1 criteria.
- Performance status of 1 or less on the ECOG scale.
- Adequate organ function based on specified lab values (e.g., neutrophil count, platelets, hemoglobin, renal and liver function).
- QTcF less than 480 milliseconds.
- Female subjects of childbearing potential have a negative serum pregnancy test.
- Willingness to use effective contraception during treatment and for 90 days after the last dose.
- Provided a tumor tissue sample (archival or new biopsy).
You will not qualify if you...
- Received cancer therapy or radiotherapy within 2 weeks or 5 half-lives before first dose.
- Not recovered to CTCAE Grade 1 or better from prior therapy side effects, except alopecia or mild neuropathy.
- Used investigational device or had major surgery within 4 weeks before first dose.
- Prior treatment targeting CD11b receptor.
- Expected to need other cancer therapies during the study.
- On chronic systemic steroids above replacement dose or immunosuppressive drugs.
- History of another malignancy unless disease-free for at least 2 years.
- Active CNS metastases or carcinomatous meningitis unless asymptomatic and untreated.
- Active autoimmune disease.
- Active infection requiring systemic treatment.
- Interstitial lung disease or history of pneumonitis requiring steroids.
- Symptomatic ascites or pleural effusion.
- Previous hematopoietic stem cell or solid organ transplant.
- Active Hepatitis B infection above specified viral load.
- Received live-virus vaccine within 4 weeks or mRNA vaccine within 4 months before first dose.
- Cardiovascular events within 3 months before first dose (e.g., deep vein thrombosis, myocardial infarction).
- Allergy to any ASD141 components.
- History of severe hypersensitivity or anaphylaxis.
- Pregnant, breastfeeding, or expecting to conceive/father children during study.
- Any condition or therapy that could interfere with study participation or results, as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
2
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
I
I-FANG TSAI, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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