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Antibody-Drug conjugate takes aim at relapsed ovarian cancer

NCT ID NCT07816666

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether torvutatug samrotecan, alone or with bevacizumab, works better than standard care as maintenance therapy for people with platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer. The trial enrolls about 600 participants who have had one or two prior lines of systemic treatment and whose cancer returned at least six months after platinum chemotherapy. The main goal is to measure how long participants live without their cancer progressing.

What this could mean

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

Active substance
torvutatug samrotecan, an antibody-drug conjugate that targets folate receptor alpha and delivers a topoisomerase I inhibitor
What this could lead to
If it works, this could offer a new maintenance option that delays cancer progression for people whose ovarian cancer has come back after platinum chemotherapy.
What could go wrong
The drug is still experimental and may not outperform standard maintenance therapy, or it could add side effects without a clear survival benefit. Results from this trial will take years to mature.

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 600 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

Oct 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.

Inclusion Criteria: * Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. * Provision of an archival FFPE tumour sample * Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy. * Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment * Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment. * Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation. * Participants with non-progressive disease upon completion of PBC in their current line of treatment. * Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance). Exclusion Criteria: * Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours. * Participants with history of (non-infectious) ILD/pneumonitis that required steroids, or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening * Participants with non-healing wound, active ulcer, or bone fracture (not applicable if not receiving bevacizumab) * Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab) * Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ovarian Epithelial fallopian tube neoplasm ovarian cancer primary peritoneal carcinoma

As listed by the trial registrant

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

Platinum-sensitive relapsed epithelial ovarian cancer Platinum-sensitive relapsed fallopian tube cancer Platinum-sensitive relapsed primary peritoneal cancer

How to take part

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

  1. The places running it

    79 sites in 11 countries. 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

  • Research Site

    Anchorage, Alaska, 99508, United States

  • Research Site

    Columbia, Maryland, 21044, United States

  • Research Site

    Detroit, Michigan, 48201, United States

  • Research Site

    Albany, New York, 12206, United States

  • Research Site

    Bay Shore, New York, 11706, United States

  • Research Site

    Greenlawn, New York, 11740, United States

  • Research Site

    New Hyde Park, New York, 11042, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    Rego Park, New York, 11374, United States

  • Research Site

    Cleveland, Ohio, 44111, United States

  • Research Site

    Cleveland, Ohio, 44195, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Mayfield Heights, Ohio, 44124, United States

  • Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    Willow Grove, Pennsylvania, 19090, United States

  • Research Site

    Morgantown, West Virginia, 26506, United States

  • Research Site

    Auchenflower, 4066, Australia

  • Research Site

    Blacktown, 2148, Australia

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Liverpool, 2170, Australia

  • Research Site

    Porto Alegre, 90035903, Brazil

  • Research Site

    São Caetano do Sul, 09541-270, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São José dos Campos, 12210-030, Brazil

  • Research Site

    São Paulo, 01327-001, Brazil

  • Research Site

    Teresina, 64049-200, Brazil

  • Research Site

    Vitória, 29043-260, Brazil

  • Research Site

    Abbotsford British Columbia, British Columbia, V2S0C2, Canada

  • Research Site

    Montreal, Quebec, H2X 0A9, Canada

  • Research Site

    Montreal, Quebec, H3A 1A1, Canada

  • Research Site

    Beijing, 100210, China

  • Research Site

    Guangdong Province, 510060, China

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Bad Homburg, 61352, Germany

  • Research Site

    Bonn, 53127, Germany

  • Research Site

    Brandenburg, 14770, Germany

  • Research Site

    Gütersloh, 33332, Germany

  • Research Site

    Homburg, 66421, Germany

  • Research Site

    Kassel, 34125, Germany

  • Research Site

    Mainz, 55131, Germany

  • Research Site

    Mannheim, 68167, Germany

  • Research Site

    Wiesbaden, 65189, Germany

  • Research Site

    Ahmedabad, 380060, India

  • Research Site

    Bangalore, 560004, India

  • Research Site

    Gurgaon, 122002, India

  • Research Site

    Kottayam, 686008, India

  • Research Site

    Madurai, 625107, India

  • Research Site

    Nashik, 422 009, India

  • Research Site

    Nashik, 422002, India

  • Research Site

    New Delhi, 11029, India

  • Research Site

    Vadodara, 391760, India

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Fukushima, 960-1295, Japan

  • Research Site

    Kobe, 650-0047, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kyoto, 612-8555, Japan

  • Research Site

    Minatoku, 105-8471, Japan

  • Research Site

    Natori-shi, 981-1293, Japan

  • Research Site

    Sagamihara-shi, 252-0375, Japan

  • Research Site

    Shinjuku-ku, 160-0023, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Toyoake-shi, 470-1192, Japan

  • Research Site

    Yokohama, 236-0004, Japan

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 135-710, South Korea

  • Research Site

    Seoul, 5505, South Korea

  • Research Site

    Kaohsiung City, 81362, Taiwan

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Bangkok, 10210, Thailand

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Muang, 50200, Thailand