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

NCT07055594 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SOA101-CL-Proto-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 metastatic solid tumor treatment.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Area Under the Curve of SOA101 (AUC)

  Up to end of study visit (90 days after the last dose)

• Maximum observed plasma concentration of SOA101 (Cmax)

  Up to end of study visit (90 days after the last dose)

• Half-life of SOA101 (T1/2)

  Up to end of study visit (90 days after the last dose)

• Overall Response Rate (ORR)

  Up to end of study visit (90 days after the last dose)

Study Arms (1)

SOA101

EXPERIMENTAL

Drug: SOA101

Interventions

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.

SOA101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shine-On Biomedical Co., Ltd.: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 39234811 RESULT

Central Study Contacts

Jennifer Ho

CONTACT

+886423272888; rd005@shineon-bio.com

Oscar Yang

CONTACT

rd009@shineon-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 9, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)