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

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer; Platinum-resistant Ovarian Cancer; Primary Peritoneal Cancer
• Intervention / Treatment: Drug: Luveltamab tazevibulin; Drug: Pegfilgrastim; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin; Drug: Topotecan

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Centre Wesley
  • Western Australia
    • Subiaco, Western Australia, Australia, WA6008
      • St John of God Subiaco Hospital
• Canada
  • Toronto, Canada, M5G 1X6
    • Princess Margaret Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centere (MUHC)-Glen Site
    • Québec, Quebec, Canada, QC G1R 2J6
      • Centre Hospitalier Universitaire de Quebec (CHUQ) - L'Hotel Dieu de Quebec
• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Holon, Israel, 5822012
    • The Edith Wolfson Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
• New Zealand
  • Wellington Region
    • Newtown, Wellington Region, New Zealand, 6021
      • Health New Zealand - Te Whatu Ora Capital, Coast, and Hutt Valley - Wellington Regional Hospital
• Singapore
  • Novena, Singapore, 329563
    • Curie Centre, Oncology centre
  • Pasir Panjang, Singapore, 119228
    • National University Cancer Institute (NCIS)
  • Singapore, Singapore, 168583
    • National Cancer Center Singapore
• South Korea
  • Daegu, South Korea, 42061
    • Keimyung University Dongsan Hospital
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Incheon, South Korea, 21565
    • Gachon University Gil Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 03722
    • Yonsei University, Severance Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC-Hope
  • California
    • Daly City, California, United States, 94015
      • Sutter Health
    • San Diego, California, United States, 92103
      • Scripps Health
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Health South Florida (BHSF) - Miami Cancer Institute
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Tampa, Florida, United States, 33612
      • USF Research & Innovation
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • Savannah, Georgia, United States, 31405
      • Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Chan Medical School
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Optimum Clinical Research Group
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • West Islip, New York, United States, 11795
      • Good Samaritan Hospital Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Pitt County Memorial Hospital, Inc. ECU Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University Center
    • Kettering, Ohio, United States, 45429
      • Kettering Health
    • Sylvania, Ohio, United States, 43560
      • ProMedica Flower Hospital
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon, PC
    • Portland, Oregon, United States, 97213-2933
      • Providence Gynecologic Oncology Clinic
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Oncology
    • Dallas, Texas, United States, 75246
      • Texas Oncology-DFW
    • San Antonio, Texas, United States, 78240
      • Texas Oncology-San Antonio
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center - Temple (Temple Clinic)
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center - Digestive Disease Institute - Liver Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Luveltamab tazevibulin dose Cohort A; 5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards	Drug: Luveltamab tazevibulin; Luveltamab tazevibulin is an antibody-drug conjugate targeting FOLR1. It consists of an IgG1 antibody (SP8166) conjugated to cleavable 3-3-aminophenyl hemiasterlin drug-linkers at 4 sites. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.; Other Names: STRO-002; Luvelta; Drug: Pegfilgrastim; Pegfilgrastim or pegylated G-CSF is approved and used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs. It increases the proliferation and differentiation of neutrophils.; Other Names: Neulasta
Experimental: Luveltamab tazevibulin dose Cohort B; 4.3 mg/kg q3w	Drug: Luveltamab tazevibulin; Luveltamab tazevibulin is an antibody-drug conjugate targeting FOLR1. It consists of an IgG1 antibody (SP8166) conjugated to cleavable 3-3-aminophenyl hemiasterlin drug-linkers at 4 sites. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.; Other Names: STRO-002; Luvelta
Active Comparator: Part 2: IC Chemotherapy; Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 q4w or 1000mg/m2 on Days 1 and 8 q3w; Paclitaxel 80 mg/m2 on Days 1, 8, and 15 q4w; Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 q4w; Topotecan 4.0 mg/m2on Day 1, 8, and 15 q4w or 1.25 mg/m2 on Days 1 - 5 q3w	Drug: Gemcitabine; Gemcitabine is a chemotherapy regimen used for treating platinum-resistant ovarian cancer. It inhibits ribonucleotide reductase and DNA polymerase, hindering tumor cell growth and promoting cell death.; Drug: Paclitaxel; Paclitaxel is a chemotherapy regimen approved for treatment of previously treated ovarian cancer. It stabilizes microtubules, inhibiting tumor cell replication.; Drug: Pegylated liposomal doxorubicin; Pegylated liposomal doxorubicin is a chemotherapy regimen approved for treating platinum-resistant ovarian cancer. It inhibits DNA and RNA synthesis by intercalating between base pairs, obstructing tumor cell division.; Drug: Topotecan; Topotecan is a chemotherapy regimen approved for treatment of metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. It binds to topoisomerase I inducing DNA breaks and subsequent tumor cell apoptosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	time between the date of first dose and the first date of documented progression or death	up to 24 months
Objective Response Rate (ORR)	Best response of complete response (CR) or partial response (PR) per RECIST 1.1.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time between date of first dose and date of death due to an cause or end of study.	up to 24 months
Duration of Response (DOR)	Confirmed CR or PR from the first documented response to the date of documented disease progression or death.	up to 24 months
Incidence and severity of adverse events [Safety and tolerability]	Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.	up to 24 months
Quality of life (QLQ-OV28)	Quality of Life Questionnaire Ovarian Cancer 28 is a 28-item ovarian cancer supplemental module that evaluates the quality of life of ovarian cancer patients. It assesses abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning.	up to 24 months

Collaborators and Investigators

• Sponsor: Sutro Biopharma, Inc.
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT); Asia-Pacific Gynecologic Oncology Trials Group (APGOT)

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Actual): August 26, 2025
• Study Completion (Actual): August 26, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: folate receptor alpha; antibody drug conjugate; FRα; FOLR1; FolRα; Luveltamab tazevibulin; STRO-002; luvelta
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Fallopian Tube Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Paclitaxel; Topotecan; liposomal doxorubicin; pegfilgrastim
• Other Study ID Numbers: STRO-002-GM3; GOG-3086 (Other Identifier: GOG Foundation); ENGOT-OV79 (Other Identifier: European Network of Gynaecological Oncological Trial Groups); GEICO-134-O (Other Identifier: European Network of Gynaecological Oncological Trial Groups); APGOT-OV9 (Other Identifier: Asia-Pacific Gynecologic Oncology Trials Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No