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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOA101 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOA101 | Drug | Participants will receive SOA101. The RP2D will be determined based on the results of the Phase I study. During the dose expansion phase, participants will receive SOA101 at the RP2D regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of SOA101 for Phase I | from start until 3 months after the last dosing | |
| Objective Response Rate (ORR) of SOA101 for Phase IIa | from start until 3 months after the last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of SOA101 (AUC) | Pharmacokinetics (PK) parameters | Up to end of study visit (90 days after the last dose) |
| Maximum observed plasma concentration of SOA101 (Cmax) | Pharmacokinetics (PK) parameters |
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Inclusion Criteria:
Male or female subjects aged ≥ 18 years old.
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:
Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.
At least one measurable lesion
Adequate organ function
Female subject must either not be of childbearing potential or a negative pregnancy test
Non-vasectomized male subjects must practice highly effective contraception
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ho | Contact | +886423272888 | rd005@shineon-bio.com | |
| Oscar Yang | Contact | rd009@shineon-bio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Recruiting | Taichung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39234811 | Result | Lin YC, Chen MC, Huang SW, Chen Y, Ho JH, Lin FY, Tan XT, Chiang HC, Huang CC, Tu CY, Cho DY, Chiu SC. Targeting Dual Immune Checkpoints PD-L1 and HLA-G by Trispecific T Cell Engager for Treating Heterogeneous Lung Cancer. Adv Sci (Weinh). 2024 Nov;11(41):e2309697. doi: 10.1002/advs.202309697. Epub 2024 Sep 5. |
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| Up to end of study visit (90 days after the last dose) |
| Half-life of SOA101 (T1/2) | Pharmacokinetics (PK) parameters | Up to end of study visit (90 days after the last dose) |
| Overall Response Rate (ORR) | Evaluation of anti-tumor activity of SOA101 | Up to end of study visit (90 days after the last dose) |