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Ovarian CancerPhase 2/3NCT05870748

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

A Phase 2/3 study testing Luveltamab tazevibulin, Pegfilgrastim and Gemcitabine in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Sutro Biopharma, Inc. at 63 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Luveltamab tazevibulin, Pegfilgrastim and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
63 sitesin 7 countries
Study dates
12 Jul 2023to 26 Aug 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
  • Age ≥ 18 years
  • ECOG performance status 0 to 1
  • Positive FOLR1 expression per central laboratory testing
  • Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens
  • Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
  • At least 1 measurable target lesion per RECIST v1.1
  • Adequate organ function

Who cannot join

  • Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas
  • Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
  • Primary platinum-refractory disease
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
  • 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
  • Previous solid organ transplantation
  • History or clinical signs of meningeal or active central nervous system involvement
  • Concurrent participation in another therapeutic treatment trial

Trial locations and contacts

63 sites in 7 countries.

63 sites in 7 countries

United States37 sites

  • Optimum Clinical Research Group

    Albuquerque, New Mexico, 87109

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Ohio State University Center

    Columbus, Ohio, 43210

  • Texas Oncology

    Dallas, Texas, 75231

  • Texas Oncology-DFW

    Dallas, Texas, 75246

  • Sutter Health

    Daly City, California, 94015

  • Oncology Associates of Oregon, PC

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Pitt County Memorial Hospital, Inc. ECU Medical Center

    Greenville, North Carolina, 27834

  • Kettering Health

    Kettering, Ohio, 45429

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

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

    Miami, Florida, 33176

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • NYU Langone Health

    New York, New York, 10016

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Providence Gynecologic Oncology Clinic

    Portland, Oregon, 97213-2933

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78240

  • Scripps Health

    San Diego, California, 92103

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

    Savannah, Georgia, 31405

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

    Seattle, Washington, 98101

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • USF Research & Innovation

    Tampa, Florida, 33612

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

    Temple, Texas, 76508

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates, PC-Hope

    Tucson, Arizona, 85711

  • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center

    Tulsa, Oklahoma, 74146

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Israel7 sites

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Rambam Medical Center

    Haifa, 3109601

  • The Edith Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

South Korea7 sites

  • Keimyung University Dongsan Hospital

    Daegu, 42061

  • National Cancer Center

    Gyeonggi-do, 10408

  • Gachon University Gil Hospital

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Yonsei University, Severance Hospital

    Seoul, 03722

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

    Seoul, 06591

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Australia5 sites

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, WA6008

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada3 sites

  • McGill University Health Centere (MUHC)-Glen Site

    Montreal, Quebec, H4A 3J1

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

    Québec, Quebec, QC G1R 2J6

  • Princess Margaret Cancer Center

    Toronto, M5G 1X6

Other trials in Canada

Singapore3 sites

  • Curie Centre, Oncology centre

    Novena, 329563

  • National University Cancer Institute (NCIS)

    Pasir Panjang, 119228

  • National Cancer Center Singapore

    Singapore, 168583

Other trials in Singapore

New Zealand1 site

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

    Newtown, Wellington Region, 6021

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Being tested
Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel, Pegylated liposomal doxorubicin
Keywords
FOLR1, FolRα, FRα, folate receptor alpha, antibody drug conjugate, Luveltamab tazevibulin, STRO-002, luvelta
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Luveltamab tazevibulinDrug

    Also called STRO-002, Luvelta

    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.

  • PegfilgrastimDrug

    Also called Neulasta

    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.

  • GemcitabineDrug

    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.

  • PaclitaxelDrug

    Paclitaxel is a chemotherapy regimen approved for treatment of previously treated ovarian cancer. It stabilizes microtubules, inhibiting tumor cell replication.

  • Pegylated liposomal doxorubicinDrug

    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.

  • TopotecanDrug

    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.

Study groups in NCT05870748
Study groupRoleWhat they receive
Luveltamab tazevibulin dose Cohort AExperimental5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards
Receives: Drug: Luveltamab tazevibulin; Drug: Pegfilgrastim
Luveltamab tazevibulin dose Cohort BExperimental4.3 mg/kg q3w
Receives: Drug: Luveltamab tazevibulin
Part 2: IC ChemotherapyActive comparator* 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
Receives: Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin; Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    time between the date of first dose and the first date of documented progression or death

    Measured: up to 24 months

  2. Objective Response Rate (ORR)

    Best response of complete response (CR) or partial response (PR) per RECIST 1.1.

    Measured: up to 24 months

Secondary outcomes (4)

  1. Overall Survival (OS)

    Time between date of first dose and date of death due to an cause or end of study.

    Measured: up to 24 months

  2. Duration of Response (DOR)

    Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

    Measured: up to 24 months

  3. Incidence and severity of adverse events [Safety and tolerability]

    Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.

    Measured: up to 24 months

  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.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start12 Jul 2023
  3. Primary completion26 Aug 2025
  4. Study completion26 Aug 2025

Why it stopped: Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870748
Sponsor's protocol ID
STRO-002-GM3
Other IDs
GOG-3086, ENGOT-OV79, GEICO-134-O, APGOT-OV9
Status last verified
Apr 2025
First submitted
12 May 2023
Last updated
23 Sep 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Luveltamab tazevibulin, Pegfilgrastim and Gemcitabine in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Sutro Biopharma, Inc. at 63 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Israel, South Korea, Australia, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05870748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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