Clinical trial NCT05870748: 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
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
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
Lead sponsor: Sutro Biopharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
First posted: 2023-05-23
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 24 months
measure: Duration of Response (DOR)
timeFrame: up to 24 months
measure: Incidence and severity of adverse events [Safety and tolerability]
timeFrame: up to 24 months
measure: Quality of life (QLQ-OV28)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-Hope
state: Arizona
city: Daly City
country: United States
facility: Sutter Health
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: Baptist Health South Florida (BHSF) - Miami Cancer Institute
state: Florida
city: Tampa
country: United States
facility: USF Research & Innovation
state: Florida
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Albuquerque
country: United States
facility: Optimum Clinical Research Group
state: New Mexico
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: West Islip
country: United States
facility: Good Samaritan Hospital Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Health
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Providence Gynecologic Oncology Clinic
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-DFW
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Montréal
country: Canada
facility: McGill University Health Centere (MUHC)-Glen Site
state: Quebec
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University, Severance Hospital
city: Newtown
country: New Zealand
facility: Health New Zealand - Te Whatu Ora Capital, Coast, and Hutt Valley - Wellington Regional Hospital
state: Wellington
city: Novena
country: Singapore
facility: Curie Centre, Oncology centre
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
Study officials:
References: