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โ† Trials
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A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllShine-On Biomedical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female subjects aged โ‰ฅ 18 years old. 2. Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists: 1. Non-small cell lung cancer (NSCLC); 2. Ovarian cancer (OC); 3. Head and neck carcinoma (H\&N); 4. Breast cancer (BC); 5. Colorectal cancer (CRC). 3. Pathologically confirmed combined positive score (CPS) with โ‰ฅ 1% expression of PD-L1. 4. At least one measurable lesion 5. Adequate organ function 6. Female subject must either not be of childbearing potential or a negative pregnancy test 7. Non-vasectomized male subjects must practice highly effective contraception Exclusion Criteria: 1. Active bacterial, fungal, viral OR atypical infection requiring systemic medication. 2. Received any investigational drug within 4 weeks before screening. 3. Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection. 4. Symptomatic, unstable central nervous system malignancy OR metastasis 5. Have received organ or tissue transplantation or allogeneic cell therapies. 6. Non-adequate cardiac function 7. Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.
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What it tests

  • SOA101
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Where

1 site
China Medical University Hospital
Taichung, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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