REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

Last updated: September 18, 2025
Sponsor: Sutro Biopharma, Inc.
Overall Status: Terminated

Phase

2/3

Condition

Peritoneal Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

Topotecan

Pegfilgrastim

Paclitaxel

Clinical Study ID

NCT05870748
STRO-002-GM3
GEICO-134-O
APGOT-OV9
GOG-3086
ENGOT-OV79
  • Ages > 18
  • Female

Study Summary

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritonealcancer

  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 3prior regimens

  6. Prior bevacizumab treatment is required, if labeled and available as standard ofcare per institutional guidelines, unless subject has documented contraindication

  7. At least 1 measurable target lesion per RECIST v1.1

  8. Adequate organ function

Exclusion

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 tubulininhibitor

  3. Primary platinum-refractory disease

  4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapyor to antibody-related fusion protein treatment

  5. Pre-existing clinically significant ocular disorders, severe chronic obstructivepulmonary disease or asthma, clinically significant cardiac or cerebrovasculardisease, 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

Study Design

Total Participants: 600
Treatment Group(s): 6
Primary Treatment: Topotecan
Phase: 2/3
Study Start date:
July 12, 2023
Estimated Completion Date:
August 26, 2025

Study Description

This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1.

Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.

Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy.

Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Chris O'Brien Lifehouse

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Icon Cancer Centre Wesley

    Auchenflower 6943571, Queensland 2152274 4066
    Australia

    Site Not Available

  • St John of God Subiaco Hospital

    Subiaco 2060886, Western Australia 2058645 WA6008
    Australia

    Site Not Available

  • McGill University Health Centere (MUHC)-Glen Site

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • McGill University Health Centere (MUHC)-Glen Site

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Site Not Available

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

    Québec 6325494, Quebec 6115047 QC G1R 2J6
    Canada

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, M5G 1X6
    Canada

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto 6167865, M5G 1X6
    Canada

    Site Not Available

  • Hillel Yaffe Medical Center

    Hadera 294946, 38100
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • The Edith Wolfson Medical Center

    Holon 294751, 5822012
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem 281184, 9103102
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba 294514, 4428164
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva 293918, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan 293788, 52621
    Israel

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu, 42061
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Gyeonggi-do, 10408
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Hospital

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Yonsei University, Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

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

    Newtown, Wellington 6021
    New Zealand

    Site Not Available

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

    Newtown 6244789, Wellington Region 2179538 6021
    New Zealand

    Site Not Available

  • Curie Centre, Oncology centre

    Novena, 329563
    Singapore

    Site Not Available

  • Curie Centre, Oncology centre

    Novena 7281987, 329563
    Singapore

    Site Not Available

  • National University Cancer Institute (NCIS)

    Pasir Panjang 1880401, 119228
    Singapore

    Site Not Available

  • National Cancer Center Singapore

    Singapore, 168583
    Singapore

    Site Not Available

  • National Cancer Center Singapore

    Singapore 1880252, 168583
    Singapore

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, Gyeonggi-do 1841610 13620
    South Korea

    Site Not Available

  • Ajou University Hospital

    Suwon 1835553, Gyeonggi-do 1841610 16499
    South Korea

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu 1835329, 42061
    South Korea

    Site Not Available

  • National Cancer Center

    Gyeonggi-do 6363696, 10408
    South Korea

    Site Not Available

  • Gachon University Gil Hospital

    Incheon 1843564, 21565
    South Korea

    Site Not Available

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

    Seoul 1835848, 06591
    South Korea

    Site Not Available

  • Yonsei University, Severance Hospital

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Arizona Oncology Associates, PC-Hope

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Arizona Oncology Associates, PC-Hope

    Tucson 5318313, Arizona 5551752 85711
    United States

    Site Not Available

  • Sutter Health

    Daly City, California 94015
    United States

    Site Not Available

  • Sutter Health

    Daly City 5341430, California 5332921 94015
    United States

    Site Not Available

  • Scripps Health

    San Diego 5391811, California 5332921 92103
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

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

    Miami, Florida 33176
    United States

    Site Not Available

  • USF Research & Innovation

    Tampa, Florida 33612
    United States

    Site Not Available

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

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach 4164143, Florida 4155751 33140
    United States

    Site Not Available

  • USF Research & Innovation

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Augusta University Medical Center

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

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

    Savannah 4221552, Georgia 4197000 31405
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore 4347778, Maryland 4361885 21215
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Minneapolis 5037649, Minnesota 5037779 55404
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • Optimum Clinical Research Group

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Optimum Clinical Research Group

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Good Samaritan Hospital Medical Center

    West Islip, New York 11795
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Good Samaritan Hospital Medical Center

    West Islip 5143866, New York 5128638 11795
    United States

    Site Not Available

  • Pitt County Memorial Hospital, Inc. ECU Medical Center

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ohio State University Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Kettering Health

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Miami Valley Hospital South

    Centerville 4508204, Ohio 5165418 45459
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Ohio State University Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Kettering Health

    Kettering 4515843, Ohio 5165418 45429
    United States

    Site Not Available

  • ProMedica Flower Hospital

    Sylvania 5173572, Ohio 5165418 43560
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center

    Tulsa 4553433, Oklahoma 4544379 74146
    United States

    Site Not Available

  • Oncology Associates of Oregon, PC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Providence Gynecologic Oncology Clinic

    Portland, Oregon 97213-2933
    United States

    Site Not Available

  • Oncology Associates of Oregon, PC

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • Providence Gynecologic Oncology Clinic

    Portland 5746545, Oregon 5744337 97213-2933
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17602
    United States

    Site Not Available

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster 5197079, Pennsylvania 6254927 17602
    United States

    Site Not Available

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Texas Oncology

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Oncology-DFW

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Texas Oncology-San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Texas Oncology - The Woodlands

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Texas Oncology

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Texas Oncology-DFW

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • Texas Oncology-San Antonio

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

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

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

  • Texas Oncology - The Woodlands

    The Woodlands 4736476, Texas 4736286 77380
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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

    Seattle 5809844, Washington 5815135 98101
    United States

    Site Not Available

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