Actively Recruiting
A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
Led by Shine-On Biomedical Co., Ltd. · Updated on 2025-11-06
76
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1/HLA-G/CD3. This is a Phase I/IIa study including dose-escalation, dose optimization and dose expansion parts to exam safety, tolerability, pharmacokinetics, immunogenecity and efficacy of SOA101 on advanced or metastatic solid tumor treatment.
CONDITIONS
Official Title
A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Locally advanced or metastatic solid tumors confirmed histologically or cytologically, including non-small cell lung cancer, ovarian cancer, head and neck carcinoma, breast cancer, or colorectal cancer
- Combined positive score of PD-L1 expression at 1% or higher
- At least one measurable tumor lesion
- Adequate organ function
- Female subjects must not be of childbearing potential or have a negative pregnancy test
- Non-vasectomized male subjects must use highly effective contraception
You will not qualify if you...
- Active bacterial, fungal, viral, or atypical infection requiring systemic medication
- Received any investigational drug within 4 weeks before screening
- Confirmed active HIV without controlled disease on HAART, HBV, or HCV infection
- Symptomatic or unstable central nervous system malignancy or metastasis
- Previous organ or tissue transplantation or allogeneic cell therapies
- Inadequate cardiac function
- Known hypersensitivity to anti-PD-L1 or anti-CD3 therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
Research Team
J
Jennifer Ho
CONTACT
O
Oscar Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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