A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors (NbTAST-01)

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: SOA101

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Ho; Phone Number: +886423272888; Email: rd005@shineon-bio.com
• Study Contact Backup: Name: Oscar Yang; Email: rd009@shineon-bio.com

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Shu-Ting Chuang; Phone Number: +886422052121; Email: 008260@tool.caaumed.rg.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects aged ≥ 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 ≥ 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOA101	Drug: SOA101; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Shine-On Biomedical Co., Ltd.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: July 7, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SOA101-CL-Proto-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No