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New hope for rare ovarian cancer: drug shrinks tumors after immunotherapy fails

NCT ID NCT07168083

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 drug called sacituzumab in 22 people with a rare and aggressive type of ovarian cancer (clear cell carcinoma) that has worsened after immunotherapy. The drug is an antibody-drug conjugate designed to target and kill cancer cells. The main goal is to see how many patients have their tumors shrink by at least 30%.

What this could mean

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

Active substance
sacituzumab (SKB264)
What this could lead to
If it works, this could offer a new treatment option for a rare and aggressive ovarian cancer that has stopped responding to immunotherapy.
What could go wrong
This is a small, early-stage study with only 22 participants. The drug may not work for everyone, and side effects are possible. Results may not apply to all 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.

Participants

About 22 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

This study enrolled patients with pathologically diagnosed OCCC who had progressed after treatment with immune checkpoint inhibitors, including anti-PD-1, PD-L1, and PD-1/PD-L1+CTLA4, and subsequently received ruconazole (regardless of the number of lines of therapy received prior to immunotherapy).

Ages

18 to 70 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: * Histologically diagnosed ovarian clear cell carcinoma * Patients who have progressed on imaging assessment after receiving immunotherapy, including anti-PD-1, PD-L1, and PD-1/PD-L1+CTLA4, and subsequently received Sacituzumab. * At least one measurable lesion as assessed by RECIST, version 1.1. * Life expectancy ≥ 12 months. * Normal renal an liver function, no myelosuppression. * Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) 0-1. * Participants must have recovered from all toxicities resulting from previous treatment (recovery to \< grade 1 or protocol-specified inclusion criteria, based on a CTCAE 5.0 assessment), excluding alopecia. * Participants must be willing to participate in the study, be compliant, sign the informed consent form, and be able to adhere to protocol-specified visits and procedures. Exclusion Criteria: * Receipt of more than two lines of therapy after progression on immunotherapy. * Previous use of irinotecan or ADCs containing topoisomerase I inhibitors. * Presence or history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment * Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that prevents delayed corneal healing. * Concomitant incomplete or complete intestinal obstruction, intestinal fistula of any grade, hydronephrosis that cannot be resolved with a ureteral stent, inflammatory bowel disease or brain metastases. * Organ transplant recipient. * ≥ Grade 3 venous embolism * Active infectious disease of any grade, including tuberculosis. * Previous history of pelvic or abdominal radiation therapy to any site. * Concurrent with other types of malignant tumors. * Mental status abnormalities. * Pregnant or lactating women; or patients of childbearing potential (male or female) who are unable to use effective medical contraception during the study period and for 6 months after the end of dosing. * Any other condition deemed inappropriate for participation in this study by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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More trials for these conditions

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