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New hope for Platinum-Resistant ovarian cancer: Rina-S trial launches

NCT ID NCT07604766

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This phase 3 trial compares a new drug called Rina-S to standard chemotherapy in 82 people with platinum-resistant ovarian cancer. Participants are randomly assigned to receive either Rina-S or one of four approved chemotherapies. The goal is to see if Rina-S can delay cancer growth better than current treatments.

What this could mean

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

Active substance
Rinatabart sesutecan (Rina-S)
What this could lead to
If it works, this could offer a new treatment option for people with platinum-resistant ovarian cancer, potentially slowing cancer growth better than current chemotherapies.
What could go wrong
This is an early-stage extension study with only 82 participants, so results may not apply to everyone. Rina-S may not prove more effective than existing chemo and could have side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 82 people

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

Started

Jun 2026

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

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.

Key Inclusion Criteria: * Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. * Participants may be enrolled regardless of FRα expression level. * Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy. * Participants must have received prior treatment with the following therapies: * Platinum chemotherapy * Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance * Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor * Mirvetuximab soravtansine, if: * Mirvetuximab soravtansine is available in the enrollment region, and * The participant is eligible, and * The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision. * Participants must have platinum-resistant disease: * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \> 91 days and ≤ 183 days after the date of the last dose of platinum. * Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum. Key Exclusion Criteria: * Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor. * Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen. * History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer. * Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry. * Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility. * Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

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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

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

  1. The places running it

    17 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

  • Chongqing University Cancer Hospital - Chongqing Cancer Hospital

    RECRUITING

    Chongqing, China

  • Fudan University Shanghai Cancer Hospital

    RECRUITING

    Shanghai, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, China

  • Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)

    RECRUITING

    Nanjing, China

  • Obstetrics & Gynecology Hospital of Fudan University

    RECRUITING

    Shanghai, China

  • Shandong First Medical University Affiliated Tumor Hospital

    RECRUITING

    Jinan, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, China

  • Sun Yat-Sen Memorial Hospital

    RECRUITING

    Guangzhou, China

  • Sun Yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • West China Second University Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

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