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: August 27, 2024
Sponsor: Sutro Biopharma, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Fallopian Tube Cancer

Pelvic Cancer

Peritoneal 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:
February 29, 2028

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

    Active - Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Westmead Hospital

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • McGill University Health Centere (MUHC)-Glen Site

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto, M5G 1X6
    Canada

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Seoul National University Bundang Hospital

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

    Active - Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42061
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Gyeonggi-do, 10408
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Hospital

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Yonsei University, Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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

    Newtown, Wellington 6021
    New Zealand

    Site Not Available

  • Curie Centre, Oncology centre

    Novena, 329563
    Singapore

    Active - Recruiting

  • National Cancer Center Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • Arizona Oncology Associates, PC-Hope

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • Sutter Health

    Daly City, California 94015
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

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

    Miami, Florida 33176
    United States

    Active - Recruiting

  • USF Research & Innovation

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Optimum Clinical Research Group

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Good Samaritan Hospital Medical Center

    West Islip, New York 11795
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Ohio State University Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Kettering Health

    Kettering, Ohio 45429
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, PC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Providence Gynecologic Oncology Clinic

    Portland, Oregon 97213-2933
    United States

    Active - Recruiting

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17602
    United States

    Active - Recruiting

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Texas Oncology

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Texas Oncology-DFW

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Texas Oncology-San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Texas Oncology - The Woodlands

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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