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New hope for ovarian cancer: Rina-S faces off against chemo in major trial

NCT ID NCT07564141

Disease control Sponsor: Genmab 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 9 times

Summary

This large Phase 3 trial will test a new drug called Rina-S, alone or with bevacizumab, against standard platinum-based chemotherapy for women with ovarian cancer that has returned after initial treatment. About 688 participants will be randomly assigned to receive either the new drug or standard chemo. The main 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
Rina-S (rinatabart sesutecan) with or without bevacizumab
What this could lead to
If successful, this could offer a new treatment option for women with recurrent platinum-sensitive ovarian cancer, potentially improving how long the cancer stays under control.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The new drug may not work better than standard chemotherapy, and side effects could be similar or different.

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 688 people

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

Started

Aug 2026

Expected to finish

Nov 2031

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: * Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer. * Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \>183 days) after their last dose administration of platinum-based therapy. * Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease. * Participants must have measurable disease per RECIST v1.1 by investigator at baseline. * All participants must provide a tumor specimen. * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline. Key Exclusion Criteria: * Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors. * Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar. * Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor. * Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα). Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer malignant ovarian serous tumor ovarian cancer ovarian carcinoma ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

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

Ovarian cancer Platinum-sensitive ovarian 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

  • Danbury Hospital

    RECRUITING

    Danbury, Connecticut, 06810, United States

  • ProHealth Care Inc

    RECRUITING

    Waukesha, Wisconsin, 53188, United States

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