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New hope for Hard-to-Treat cervical cancer? drug trial targets HER2

NCT ID NCT07051486

Disease control Sponsor: Jiangsu HengRui Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial is testing a drug called SHR-A1811 in 60 women with HER2-expressing cervical cancer that has spread or returned after standard treatments. The drug is an antibody-drug conjugate designed to deliver chemotherapy directly to cancer cells. The main goal is to see how many patients' tumors shrink or disappear.

What this could mean

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

Active substance
SHR-A1811 (an antibody-drug conjugate targeting HER2)
What this could lead to
If successful, this could offer a new treatment option for people with HER2-positive cervical cancer that has not responded to standard therapies.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors in many patients.

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 60 people

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

Started

Oct 2025

Expected to finish

Aug 2026

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

Female participants only

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. Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up. 2. Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent). 3. Cervical cancer confirmed by tissue or cytological pathology. 4. Expected survival ≥ 12 weeks. 5. Normal function of important organs. 6. Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months. Exclusion Criteria: 1. Subjects with known untreated or active central nervous system (CNS) tumor metastases. 2. Subjects with other malignant tumors in the past or at the same time. 3. Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion. 4. Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment. 5. Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs. 6. Subjects with known lung damage caused by concurrent lung diseases. 7. Subjects with active pulmonary tuberculosis. 8. Subjects with poorly controlled or severe cardiovascular diseases. 9. Subjects with arterial/venous thrombotic events within 1 month before enrollment. 10. Subjects who had a serious infection within 1 month before enrollment. 11. History of immunodeficiency, including positive HIV test.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Recurrence Uterine Cervical Neoplasms

As listed by the trial registrant

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

Recurrent or metastatic cervical cancer

How to take part

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

  1. The places running it

    2 sites. 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

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350011, China

  • Shandong University Qilu Hospital

    RECRUITING

    Jinan, Shandong, 250063, China

More trials for these conditions

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