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

NCT05870748 | Terminated Phase 2 FDA Drug

• 5 other identifiers: STRO-002-GM3GOG-3086ENGOT-OV79GEICO-134-OAPGOT-OV9
• Study Type: interventional
• Target: 600
• Locations: 7 countries
• Sites: 63

Brief 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.

Conditions

Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Platinum-resistant Ovarian Cancer

Keywords

FOLR1; FolRα; FRα; folate receptor alpha; antibody drug conjugate; Luveltamab tazevibulin; STRO-002; luvelta

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall Survival (OS)

  up to 24 months

• Duration of Response (DOR)

  up to 24 months

• Incidence and severity of adverse events [Safety and tolerability]

  up to 24 months

• Quality of life (QLQ-OV28)

  up to 24 months

Study Arms (3)

Luveltamab tazevibulin dose Cohort A

EXPERIMENTAL

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; Drug: Pegfilgrastim

Luveltamab tazevibulin dose Cohort B

EXPERIMENTAL

4.3 mg/kg q3w

Drug: Luveltamab tazevibulin

Part 2: IC Chemotherapy

ACTIVE 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

Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin; Drug: Topotecan

Interventions

Luveltamab tazevibulin DRUG

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.

Also known as: STRO-002, Luvelta

Luveltamab tazevibulin dose Cohort A; Luveltamab tazevibulin dose Cohort B

Pegfilgrastim DRUG

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.

Also known as: Neulasta

Luveltamab tazevibulin dose Cohort A

Gemcitabine DRUG

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.

Part 2: IC Chemotherapy

Paclitaxel DRUG

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

Part 2: IC Chemotherapy

Pegylated liposomal doxorubicin DRUG

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.

Part 2: IC Chemotherapy

Topotecan DRUG

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.

Part 2: IC Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (63)

Arizona Oncology Associates, PC-Hope

Tucson, Arizona, 85711, United States

Location

Sutter Health

Daly City, California, 94015, United States

Location

Scripps Health

San Diego, California, 92103, United States

Location

MedStar Washington Hospital Center

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

Location

Baptist Health South Florida (BHSF) - Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

USF Research & Innovation

Tampa, Florida, 33612, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

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

Savannah, Georgia, 31405, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Optimum Clinical Research Group

Albuquerque, New Mexico, 87109, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Good Samaritan Hospital Medical Center

West Islip, New York, 11795, United States

Location

Pitt County Memorial Hospital, Inc. ECU Medical Center

Greenville, North Carolina, 27834, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Center

Columbus, Ohio, 43210, United States

Location

Kettering Health

Kettering, Ohio, 45429, United States

Location

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center

Tulsa, Oklahoma, 74146, United States

Location

Oncology Associates of Oregon, PC

Eugene, Oregon, 97401, United States

Location

Providence Gynecologic Oncology Clinic

Portland, Oregon, 97213-2933, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Oncology

Dallas, Texas, 75231, United States

Location

Texas Oncology-DFW

Dallas, Texas, 75246, United States

Location

Texas Oncology-San Antonio

San Antonio, Texas, 78240, United States

Location

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

Temple, Texas, 76508, United States

Location

Texas Oncology - The Woodlands

The Woodlands, Texas, 77380, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Virginia Mason Medical Center - Digestive Disease Institute - Liver Center

Seattle, Washington, 98101, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Icon Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

Location

St John of God Subiaco Hospital

Subiaco, Western Australia, WA6008, Australia

Location

McGill University Health Centere (MUHC)-Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

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

Québec, Quebec, QC G1R 2J6, Canada

Location

Princess Margaret Cancer Center

Toronto, M5G 1X6, Canada

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

The Edith Wolfson Medical Center

Holon, 5822012, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

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

Newtown, Wellington Region, 6021, New Zealand

Location

Curie Centre, Oncology centre

Novena, 329563, Singapore

Location

National University Cancer Institute (NCIS)

Pasir Panjang, 119228, Singapore

Location

National Cancer Center Singapore

Singapore, 168583, Singapore

Location

Seoul National University Bundang Hospital

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

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42061, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Gachon University Gil Hospital

Incheon, 21565, South Korea

Location

Yonsei University, Severance Hospital

Seoul, 03722, South Korea

Location

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

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

pegfilgrastim; Gemcitabine; Paclitaxel; liposomal doxorubicin; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: July 12, 2023
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); IL (7); SG (3); US (37); NZ (1); KR (7); AU (5)