Solid TumorsPhase 1/2NbTAST-01NCT07055594
A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
A Phase 1/2 study testing SOA101 in people with Solid Tumors, run by Shine-On Biomedical Co., Ltd. at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- SOA101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2025to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Non-small cell lung cancer (NSCLC);
- Ovarian cancer (OC);
- Head and neck carcinoma (H\&N);
- Breast cancer (BC);
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- Colorectal cancer (CRC).
- 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
Who cannot join
- 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, unstable central nervous system malignancy OR metastasis
- Have received organ or tissue transplantation or allogeneic cell therapies.
- Non-adequate cardiac function
- Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oscar Yang contact
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Shu-Ting Chuang, +886422052121, 008260@tool.caaumed.rg.tw
About this study
Official title: A Phase I/IIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.
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
- Solid Tumors
- Being tested
- SOA101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOA101Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SOA101 | Experimental | Not described Receives: Drug: SOA101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of SOA101 for Phase I
Measured: from start until 3 months after the last dosing
Objective Response Rate (ORR) of SOA101 for Phase IIa
Measured: from start until 3 months after the last dosing
Secondary outcomes (4)
Area Under the Curve of SOA101 (AUC)
Pharmacokinetics (PK) parameters
Measured: Up to end of study visit (90 days after the last dose)
Maximum observed plasma concentration of SOA101 (Cmax)
Pharmacokinetics (PK) parameters
Measured: Up to end of study visit (90 days after the last dose)
Half-life of SOA101 (T1/2)
Pharmacokinetics (PK) parameters
Measured: Up to end of study visit (90 days after the last dose)
Overall Response Rate (ORR)
Evaluation of anti-tumor activity of SOA101
Measured: Up to end of study visit (90 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start30 Jul 2025
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shine-On Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055594
- Sponsor's protocol ID
- SOA101-CL-Proto-01
- Acronym
- NbTAST-01
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39234811
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07055594
- Acronym / sponsor ID
- NbTAST-01 / SOA101-CL-Proto-01
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shine-On Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOA101 | Experimental | Drug: SOA101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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, unstable central nervous system malignancy OR metastasis
- Have received organ or tissue transplantation or allogeneic cell therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOA101Participants 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. | Drug | SOA101 |
Primary outcome
Maximum Tolerated Dose (MTD) of SOA101 for Phase I
Time frame: from start until 3 months after the last dosing
Objective Response Rate (ORR) of SOA101 for Phase IIa
Time frame: from start until 3 months after the last dosing
4 secondary outcomes
Area Under the Curve of SOA101 (AUC)
Time frame: Up to end of study visit (90 days after the last dose)
Maximum observed plasma concentration of SOA101 (Cmax)
Time frame: Up to end of study visit (90 days after the last dose)
Half-life of SOA101 (T1/2)
Time frame: Up to end of study visit (90 days after the last dose)
Overall Response Rate (ORR)
Time frame: Up to end of study visit (90 days after the last dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Results publication: PubMed 39234811Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar Yang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SOA101 in people with Solid Tumors, run by Shine-On Biomedical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ho (+886423272888, rd005@shineon-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of SOA101 for Phase I (time frame: from start until 3 months after the last dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07055594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.