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New hope for tough ovarian cancer? trial tests smart drug vs chemo

NCT ID NCT05870748

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested a new drug called luveltamab tazevibulin (STRO-002) against standard chemotherapy in 600 women with ovarian cancer that had stopped responding to platinum treatment. The drug targets a protein (FOLR1) found on many ovarian cancer cells. The trial was terminated early, so it is unclear if the drug works better than chemo.

What this could mean

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

Active substance
Luveltamab tazevibulin (a targeted antibody-drug conjugate)
What this could lead to
If it works, this could offer a new treatment option for women with hard-to-treat ovarian cancer that has stopped responding to platinum-based chemotherapy.
What could go wrong
The trial was terminated early, so results are limited. The drug is still experimental, and side effects from the chemotherapy-like payload may be significant.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

600 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2025

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: 1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer 2. Age ≥ 18 years 3. ECOG performance status 0 to 1 4. Positive FOLR1 expression per central laboratory testing 5. Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens 6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication 7. At least 1 measurable target lesion per RECIST v1.1 8. Adequate organ function Exclusion Criteria: 1. Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas 2. Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor 3. Primary platinum-refractory disease 4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment 5. Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition 6. Previous solid organ transplantation 7. History or clinical signs of meningeal or active central nervous system involvement 8. Concurrent participation in another therapeutic treatment trial

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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.

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Arizona Oncology Associates, PC-Hope

    Tucson, Arizona, 85711, United States

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Baptist Health South Florida (BHSF) - Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Baylor Scott & White Medical Center - Temple (Temple Clinic)

    Temple, Texas, 76508, United States

  • Centre Hospitalier Universitaire de Quebec (CHUQ) - L'Hotel Dieu de Quebec

    Québec, Quebec, QC G1R 2J6, Canada

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Curie Centre, Oncology centre

    Novena, 329563, Singapore

  • Gachon University Gil Hospital

    Incheon, 21565, South Korea

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795, United States

  • Health New Zealand - Te Whatu Ora Capital, Coast, and Hutt Valley - Wellington Regional Hospital

    Newtown, Wellington Region, 6021, New Zealand

  • Hillel Yaffe Medical Center

    Hadera, 38100, Israel

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066, Australia

  • Keimyung University Dongsan Hospital

    Daegu, 42061, South Korea

  • Kettering Health

    Kettering, Ohio, 45429, United States

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • McGill University Health Centere (MUHC)-Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Miami Valley Hospital South

    Centerville, Ohio, 45459, United States

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405, United States

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Cancer Center Singapore

    Singapore, 168583, Singapore

  • National University Cancer Institute (NCIS)

    Pasir Panjang, 119228, Singapore

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Ohio State University Center

    Columbus, Ohio, 43210, United States

  • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center

    Tulsa, Oklahoma, 74146, United States

  • Oncology Associates of Oregon, PC

    Eugene, Oregon, 97401, United States

  • Optimum Clinical Research Group

    Albuquerque, New Mexico, 87109, United States

  • Pitt County Memorial Hospital, Inc. ECU Medical Center

    Greenville, North Carolina, 27834, United States

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Princess Margaret Cancer Center

    Toronto, M5G 1X6, Canada

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560, United States

  • Providence Gynecologic Oncology Clinic

    Portland, Oregon, 97213-2933, United States

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Scripps Health

    San Diego, California, 92103, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215, United States

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, WA6008, Australia

  • Sutter Health

    Daly City, California, 94015, United States

  • Texas Oncology

    Dallas, Texas, 75231, United States

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380, United States

  • Texas Oncology-DFW

    Dallas, Texas, 75246, United States

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78240, United States

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Edith Wolfson Medical Center

    Holon, 5822012, Israel

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • USF Research & Innovation

    Tampa, Florida, 33612, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Mason Medical Center - Digestive Disease Institute - Liver Center

    Seattle, Washington, 98101, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Yonsei University, Severance Hospital

    Seoul, 03722, South Korea

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