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New 'Tri-Specific' antibody takes aim at Hard-to-Treat cancers

NCT ID NCT07055594

Disease control Sponsor: Shine-On Biomedical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called SOA101, a special antibody that can attach to both cancer cells and immune cells to help the immune system attack tumors. It is for people with advanced solid tumors (like lung, ovarian, or breast cancer) who have no other standard treatment options. The trial has two phases: first, finding the safest dose, and then checking if the drug shrinks tumors. About 76 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SOA101 (a trispecific antibody that targets cancer cells and immune cells)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects from immune activation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer colorectal cancer head and neck carcinoma non-small cell lung carcinoma ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China Medical University Hospital

    RECRUITING

    Taichung, Taiwan

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