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

NCT ID: NCT07055594

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOA101

Group Type EXPERIMENTAL

SOA101

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shine-On Biomedical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jennifer Ho

Role: CONTACT

Phone: +886423272888

Email: [email protected]

Oscar Yang

Role: CONTACT

Email: [email protected]

Facility Contacts

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Shu-Ting Chuang

Role: primary

References

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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.

Reference Type RESULT
PMID: 39234811 (View on PubMed)

Other Identifiers

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SOA101-CL-Proto-01

Identifier Type: -

Identifier Source: org_study_id