Trial Title:
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
NCT ID:
NCT05870748
Condition:
Ovarian Cancer
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Platinum-resistant Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Paclitaxel
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Topotecan
Conditions: Keywords:
FOLR1
FolRα
FRα
folate receptor alpha
antibody drug conjugate
Luveltamab tazevibulin
STRO-002
luvelta
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Luveltamab tazevibulin
Description:
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.
Arm group label:
Luveltamab tazevibulin dose Cohort A
Arm group label:
Luveltamab tazevibulin dose Cohort B
Other name:
STRO-002
Other name:
Luvelta
Intervention type:
Drug
Intervention name:
Pegfilgrastim
Description:
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.
Arm group label:
Luveltamab tazevibulin dose Cohort A
Other name:
Neulasta
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
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.
Arm group label:
Part 2: IC Chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel is a chemotherapy regimen approved for treatment of previously treated ovarian
cancer. It stabilizes microtubules, inhibiting tumor cell replication.
Arm group label:
Part 2: IC Chemotherapy
Intervention type:
Drug
Intervention name:
Pegylated liposomal doxorubicin
Description:
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.
Arm group label:
Part 2: IC Chemotherapy
Intervention type:
Drug
Intervention name:
Topotecan
Description:
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.
Arm group label:
Part 2: IC Chemotherapy
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Oncology Associates, PC-Hope
Address:
City:
Tucson
Zip:
85711
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stacey Kimbell
Phone:
520-886-0206
Email:
stacey.kimbell@usoncology.com
Investigator:
Last name:
Joseph Buscema, MD
Email:
Principal Investigator
Facility:
Name:
Sutter Health
Address:
City:
Daly City
Zip:
94015
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia Rivera Penafiel
Phone:
415-600-1102
Email:
julia.riverapenafiel@sutterhealth.org
Investigator:
Last name:
John Chan, MD
Email:
Principal Investigator
Facility:
Name:
MedStar Washington Hospital Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hiwot Guebre-Xabiher
Phone:
202-877-9386
Email:
Hiwot.Guebre-Xabiher@medstar.net
Investigator:
Last name:
Ebony Hoskins, MD
Email:
Principal Investigator
Facility:
Name:
Baptist Health South Florida (BHSF) - Miami Cancer Institute
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hany Fleitas
Phone:
786-527-8349
Email:
hany.fleitas@baptisthealth.net
Investigator:
Last name:
John Diaz, MD
Email:
Principal Investigator
Facility:
Name:
USF Research & Innovation
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kathleen Murillo
Phone:
813-844-8221
Email:
kmurillo@tgh.org
Investigator:
Last name:
Matthew Anderson, MD
Email:
Principal Investigator
Facility:
Name:
Sinai Hospital of Baltimore
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Loomis
Phone:
410-601-9082
Email:
mloomis@lifebridgehealth.org
Investigator:
Last name:
Pallavi Kumar, MD
Email:
Principal Investigator
Facility:
Name:
University of Massachusetts Chan Medical School
Address:
City:
Worcester
Zip:
01655
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lindsey Allen
Phone:
774-455-4446
Email:
lindsey.allen@umassmed.edu
Investigator:
Last name:
Susan Zweizig, MD
Email:
Principal Investigator
Facility:
Name:
Minnesota Oncology Hematology
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nykole Starks
Phone:
612-884-6331
Email:
nykole.starks@usoncology.com
Investigator:
Last name:
Lauren Bollinger, MD
Email:
Principal Investigator
Facility:
Name:
Nebraska Methodist Hospital
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Khaliq Nasrati
Phone:
402-354-7892
Email:
khaliq.nasrati@nmhs.org
Investigator:
Last name:
Brent Tierney, MD
Email:
Principal Investigator
Facility:
Name:
Optimum Clinical Research Group
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katy Chalamidas
Phone:
505-372-1968
Email:
kchalamidas@optimumresearchabq.com
Investigator:
Last name:
Karen Finkelstein, MD
Email:
Principal Investigator
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Keith Kallas
Phone:
212-998-1212
Email:
Keith.Kallas@nyulangone.org
Investigator:
Last name:
Bhavana Pothuri, MD
Email:
Principal Investigator
Facility:
Name:
Good Samaritan Hospital Medical Center
Address:
City:
West Islip
Zip:
11795
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephanie Solito
Phone:
631-417-8611
Email:
stephanie.solito@chsli.org
Investigator:
Last name:
Yi-Chun Lee, MD
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati Medical Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cara King
Phone:
646-942-1786
Email:
king4cg@ucmail.uc.edu
Investigator:
Last name:
Amanda Jackson, MD
Email:
Principal Investigator
Facility:
Name:
Ohio State University Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordyn Burks
Phone:
614-685-4311
Email:
Jordyn.Burks@osumc.edu
Investigator:
Last name:
Floor Backes, MD
Email:
Principal Investigator
Facility:
Name:
Kettering Health
Address:
City:
Kettering
Zip:
45429
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Geyer
Phone:
937-395-6017
Email:
Daniel.geyer@ketteringhealth.org
Investigator:
Last name:
Thomas Reid, MD
Email:
Principal Investigator
Facility:
Name:
Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center
Address:
City:
Tulsa
Zip:
74146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Marangoni, PhD
Phone:
918-505-3200
Phone ext:
4195
Email:
Daniel.Marangoni@ocsri.org
Investigator:
Last name:
Michael Gold, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Associates of Oregon, PC
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tawna Kiely
Phone:
541-683-5001
Email:
tawna.kiely@usoncology.com
Investigator:
Last name:
Charles Anderson, MD
Email:
Principal Investigator
Facility:
Name:
Providence Gynecologic Oncology Clinic
Address:
City:
Portland
Zip:
97213-2933
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Darus
Phone:
503-215-2075
Email:
christopher.darus@providence.org
Investigator:
Last name:
Christopher Darus, MD
Email:
Principal Investigator
Facility:
Name:
Lancaster General Hospital
Address:
City:
Lancaster
Zip:
17602
Country:
United States
Status:
Recruiting
Contact:
Last name:
Krista Budzik
Phone:
717-544-0511
Email:
Krista.Budzik@pennmedicine.upenn.edu
Investigator:
Last name:
Bethany Bustamante, MD
Email:
Principal Investigator
Facility:
Name:
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Douglas
Phone:
215-481-4429
Email:
ashley.douglas.2@jefferson.edu
Investigator:
Last name:
Russell Schilder, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Morgan Heim
Phone:
214-384-9107
Email:
morgan.heim@usoncology.com
Investigator:
Last name:
Kristi McIntyre, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology-DFW
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dominique Marquez
Phone:
214-370-1000
Email:
dominique.marquez1@usoncology.com
Investigator:
Last name:
Brandon Sawyer, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology-San Antonio
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Bock
Phone:
210-595-5300
Email:
alice.bock@usoncology.com
Investigator:
Last name:
Antonio Santillan-Gomez, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - The Woodlands
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Howell
Email:
melissa.howell@usoncology.com
Investigator:
Last name:
Christine Lee, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristi Ben-Barka
Phone:
703-280-5390
Email:
kristi.ben-barka@usoncology.com
Investigator:
Last name:
Chao Yin, MD
Email:
Principal Investigator
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Shuo Zhang
Phone:
+61 2 8514 0659
Email:
shirley.zhang@lh.org.au
Investigator:
Last name:
Michelle Harrison
Email:
Principal Investigator
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Emma Cet
Phone:
61293825324
Email:
Umuhan.Cet@health.nsw.gov.au
Investigator:
Last name:
Yeh Chen Lee
Email:
Principal Investigator
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kate Campbell
Phone:
0419 859 255
Email:
Kate.Campbell1@health.nsw.gov.au
Investigator:
Last name:
Bo Gao
Email:
Principal Investigator
Facility:
Name:
McGill University Health Centere (MUHC)-Glen Site
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Laura Pietrantonio
Phone:
514-934-1934 ext 31975
Email:
laura.pietrantonio@rimuhc.ca
Investigator:
Last name:
Lucy Gilbert, MD
Email:
Principal Investigator
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 1X6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Riya Agrawal
Email:
Riya.Agrawal@uhn.ca
Investigator:
Last name:
Amit Oza, MD
Email:
Principal Investigator
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
52621
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Anna Rapoport
Phone:
03-5308536
Email:
anna.rapoport@sheba.health.gov.il
Investigator:
Last name:
Ronnie Shapira, MD
Email:
Principal Investigator
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seungyeon Kwon
Phone:
+82-10-2004-4202
Email:
irin1218@gmail.com
Investigator:
Last name:
Kidong Kim, MD
Email:
Principal Investigator
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Daegu
Zip:
42061
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
MyoungHee Kim
Phone:
+82-10-9258-8338
Email:
mh04088@naver.com
Investigator:
Last name:
Chi-Heum Cho, MD
Email:
Principal Investigator
Facility:
Name:
National Cancer Center
Address:
City:
Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seonhwa Lee
Phone:
+82-31-920-0856
Email:
75920@ncc.re.kr
Investigator:
Last name:
Myong Cheol Lim, MD
Email:
Principal Investigator
Facility:
Name:
Gachon University Gil Hospital
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
So Hee Choi
Phone:
+82-10-9271-7739
Email:
hihi7739@naver.com
Investigator:
Last name:
Young Saing Kim, MD
Email:
Principal Investigator
Facility:
Name:
Yonsei University, Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Saebom Kim
Phone:
+82-2-2228-2760
Email:
ekfsla2113@yuhs.ac
Investigator:
Last name:
Kidong Kim, MD
Email:
Principal Investigator
Facility:
Name:
Health New Zealand - Te Whatu Ora Capital, Coast, and Hutt Valley - Wellington Regional Hospital
Address:
City:
Newtown
Zip:
6021
Country:
New Zealand
Status:
Not yet recruiting
Contact:
Last name:
Jonathan Graham, MD
Phone:
043855999
Email:
WBCC-ClinicalTrials@ccdhb.org.nz
Investigator:
Last name:
Jonathan Graham, MD
Email:
Principal Investigator
Facility:
Name:
Curie Centre, Oncology centre
Address:
City:
Novena
Zip:
329563
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Vera Chia
Phone:
(65) 8125-7409
Email:
veraqxchen@gmail.com
Investigator:
Last name:
John Chia, MD
Email:
Principal Investigator
Facility:
Name:
National Cancer Center Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Kathyleen Garcia David
Phone:
(65) 6306-1373
Email:
kathyleen.g.d@singhealth.com.sg
Investigator:
Last name:
Elaine Lim, MD
Email:
Principal Investigator
Start date:
July 12, 2023
Completion date:
February 2028
Lead sponsor:
Agency:
Sutro Biopharma, Inc.
Agency class:
Industry
Collaborator:
Agency:
GOG Foundation
Agency class:
Other
Collaborator:
Agency:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Agency class:
Other
Collaborator:
Agency:
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
Agency class:
Other
Source:
Sutro Biopharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870748
