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

Recruitment Status
TERMINATED
(See Contacts and Locations)Verified March 2025 by Sutro Biopharma, Inc.
Sponsor
Sutro Biopharma, Inc.
Information Provided by (Responsible Party)
Sutro Biopharma, Inc.
Clinicaltrials.gov Identifier
NCT05870748
Other Study ID Numbers:
STRO-002-GM3
First Submitted
May 11, 2023
First Posted
May 22, 2023
Last Update Posted
September 22, 2025
Last Verified
March 2025

ClinicalTrials.gov processed this data on September 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Ovarian CancerEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerPlatinum-resistant Ovarian Cancer
Drug: Luveltamab tazevibulinDrug: Luveltamab tazevibulinDrug: Gemcitabine

Study Design

Study TypeInterventional
Actual Enrollment600 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleREFRaME-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)
Study Start DateJuly 11, 2023
Actual Primary Completion DateAugust 25, 2025
Actual Study Completion DateAugust 25, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
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.
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.

Outcome Measures

Primary Outcome Measures
  1. Progression Free Survival (PFS)
    time between the date of first dose and the first date of documented progression or death
  2. Objective Response Rate (ORR)
    Best response of complete response (CR) or partial response (PR) per RECIST 1.1.
Secondary Outcome Measures
  1. Overall Survival (OS)
    Time between date of first dose and date of death due to an cause or end of study.
  2. Duration of Response (DOR)
    Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
  3. Incidence and severity of adverse events [Safety and tolerability]
    Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.
  4. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsSutro Biopharma, Inc.
Locations
Arizona Oncology Associates, PC-Hope | Tucson Arizona, United States, 85711Sutter Health | Daly City California, United States, 94015Scripps Health | San Diego California, United States, 92103MedStar Washington Hospital Center | Washington D.C. District of Columbia, United States, 20010Baptist Health South Florida (BHSF) - Miami Cancer Institute | Miami Florida, United States, 33176Mount Sinai Comprehensive Cancer Center | Miami Beach Florida, United States, 33140USF Research & Innovation | Tampa Florida, United States, 33612Augusta University Medical Center | Augusta Georgia, United States, 30912Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler | Savannah Georgia, United States, 31405Sinai Hospital of Baltimore | Baltimore Maryland, United States, 21215Tufts Medical Center | Boston Massachusetts, United States, 02111University of Massachusetts Chan Medical School | Worcester Massachusetts, United States, 01655Minnesota Oncology Hematology | Minneapolis Minnesota, United States, 55404Nebraska Methodist Hospital | Omaha Nebraska, United States, 68114Optimum Clinical Research Group | Albuquerque New Mexico, United States, 87109NYU Langone Health | New York New York, United States, 10016Good Samaritan Hospital Medical Center | West Islip New York, United States, 11795Pitt County Memorial Hospital, Inc. ECU Medical Center | Greenville North Carolina, United States, 27834Wake Forest Baptist Health | Winston-Salem North Carolina, United States, 27157Miami Valley Hospital South | Centerville Ohio, United States, 45459University of Cincinnati Medical Center | Cincinnati Ohio, United States, 45219Ohio State University Center | Columbus Ohio, United States, 43210Kettering Health | Kettering Ohio, United States, 45429ProMedica Flower Hospital | Sylvania Ohio, United States, 43560Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center | Tulsa Oklahoma, United States, 74146Oncology Associates of Oregon, PC | Eugene Oregon, United States, 97401Providence Gynecologic Oncology Clinic | Portland Oregon, United States, 97213-2933Lancaster General Hospital | Lancaster Pennsylvania, United States, 17602Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital | Philadelphia Pennsylvania, United States, 19107Vanderbilt University Medical Center | Nashville Tennessee, United States, 37232Texas Oncology | Dallas Texas, United States, 75231Texas Oncology-DFW | Dallas Texas, United States, 75246Texas Oncology-San Antonio | San Antonio Texas, United States, 78240Baylor Scott & White Medical Center - Temple (Temple Clinic) | Temple Texas, United States, 76508Texas Oncology - The Woodlands | The Woodlands Texas, United States, 77380Virginia Cancer Specialists | Fairfax Virginia, United States, 22031Virginia Mason Medical Center - Digestive Disease Institute - Liver Center | Seattle Washington, United States, 98101Chris O'Brien Lifehouse | Camperdown New South Wales, Australia, 2050Prince of Wales Hospital | Randwick New South Wales, Australia, 2031Westmead Hospital | Westmead New South Wales, Australia, 2145Icon Cancer Centre Wesley | Auchenflower Queensland, Australia, 4066St John of God Subiaco Hospital | Subiaco Western Australia, Australia, WA6008McGill University Health Centere (MUHC)-Glen Site | Montreal Quebec, Canada, H4A 3J1Centre Hospitalier Universitaire de Quebec (CHUQ) - L'Hotel Dieu de Quebec | Québec Quebec, Canada, QC G1R 2J6Princess Margaret Cancer Center | Toronto , Canada, M5G 1X6Hillel Yaffe Medical Center | Hadera , Israel, 38100Rambam Medical Center | Haifa , Israel, 3109601The Edith Wolfson Medical Center | Holon , Israel, 5822012Shaare Zedek Medical Center | Jerusalem , Israel, 9103102Meir Medical Center | Kfar Saba , Israel, 4428164Rabin Medical Center | Petah Tikva , Israel, 4941492Sheba Medical Center | Ramat Gan , Israel, 52621Health New Zealand - Te Whatu Ora Capital, Coast, and Hutt Valley - Wellington Regional Hospital | Newtown Wellington Region, New Zealand, 6021Curie Centre, Oncology centre | Novena , Singapore, 329563National University Cancer Institute (NCIS) | Pasir Panjang , Singapore, 119228National Cancer Center Singapore | Singapore , Singapore, 168583Seoul National University Bundang Hospital | Seongnam-si Gyeonggi-do, South Korea, 13620Ajou University Hospital | Suwon Gyeonggi-do, South Korea, 16499Keimyung University Dongsan Hospital | Daegu , South Korea, 42061National Cancer Center | Gyeonggi-do , South Korea, 10408Gachon University Gil Hospital | Incheon , South Korea, 21565Yonsei University, Severance Hospital | Seoul , South Korea, 03722The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul , South Korea, 06591