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New drug targets Gene-Amplified breast cancers in early trial

NCT ID NCT07080619

Disease control Sponsor: Tianjin ConjuStar Biologics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new drug called SC-101 in 120 people with advanced breast cancer (triple-negative or hormone-receptor-positive) that has a specific gene change called NECTIN4 amplification. Participants receive the drug once a week through an IV. The goal is to see if the drug can shrink tumors and to check for side effects.

What this could mean

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

Active substance
SC-101 (a drug given intravenously once weekly)
What this could lead to
If it works, this could point toward a new treatment option for advanced breast cancers that have a specific gene change (NECTIN4 amplification).
What could go wrong
This is an early Phase IIa trial with only 120 people, so results may not confirm benefit. The drug may cause side effects or fail to shrink tumors.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 to 75 years

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: Age between 18 and 75 years (inclusive), regardless of gender. ECOG performance status of 0-1. Expected survival of more than 3 months, as assessed by the investigator. Fertile participants must agree to use contraception. Able to understand the trial requirements and willing and able to comply with the trial and follow-up procedures. Adequate bone marrow and organ function. NECTIN-4 gene amplification positive. Exclusion Criteria: Unstable central nervous system tumors. Adverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤1. A history of severe cardiovascular or cerebrovascular disease.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer triple-negative breast carcinoma

As listed by the trial registrant

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

HR+ breast cancer TNBC - triple-negative breast cancer

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.