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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05870748
Other study ID # STRO-002-GM3
Secondary ID GOG-3086ENGOT-OV
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 12, 2023
Est. completion date February 2026

Study information

Verified date April 2024
Source Sutro Biopharma, Inc.
Contact Craig Berman, MD
Phone 650-801-6417
Email STRO-002ClinDev@sutrobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date February 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Australia Chris O'Brien Lifehouse Camperdown New South Wales
Australia Prince of Wales Hospital Randwick New South Wales
Australia Westmead Hospital Westmead New South Wales
Canada McGill University Health Centere (MUHC)-Glen Site Montréal Quebec
Canada Princess Margaret Cancer Center Toronto
Israel Sheba Medical Center Ramat Gan
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of National Cancer Center Gyeonggi-do
Korea, Republic of Gachon University Gil Hospital Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Yonsei University, Severance Hospital Seoul
Singapore Curie Centre, Oncology centre Novena
Singapore National Cancer Center Singapore Singapore
United States Optimum Clinical Research Group Albuquerque New Mexico
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Ohio State University Center Columbus Ohio
United States Texas Oncology Dallas Texas
United States Texas Oncology-DFW Dallas Texas
United States Sutter Health Daly City California
United States Oncology Associates of Oregon, PC Eugene Oregon
United States Virginia Cancer Specialists Fairfax Virginia
United States Kettering Health Kettering Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States Baptist Health South Florida (BHSF) - Miami Cancer Institute Miami Florida
United States Minnesota Oncology Hematology Minneapolis Minnesota
United States NYU Langone Health New York New York
United States Nebraska Methodist Hospital Omaha Nebraska
United States Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Providence Gynecologic Oncology Clinic Portland Oregon
United States Texas Oncology-San Antonio San Antonio Texas
United States USF Research & Innovation Tampa Florida
United States Texas Oncology - The Woodlands The Woodlands Texas
United States Arizona Oncology Associates, PC-Hope Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center Tulsa Oklahoma
United States MedStar Washington Hospital Center Washington District of Columbia
United States Good Samaritan Hospital Medical Center West Islip New York
United States University of Massachusetts Chan Medical School Worcester Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Sutro Biopharma, Inc. Asia-Pacific Gynecologic Oncology Trials Group (APGOT), European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Korea, Republic of,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) time between the date of first dose and the first date of documented progression or death up to 24 months
Primary Objective Response Rate (ORR) Best response of complete response (CR) or partial response (PR) per RECIST 1.1. up to 24 months
Secondary Overall Survival (OS) Time between date of first dose and date of death due to an cause or end of study. up to 24 months
Secondary Duration of Response (DOR) Confirmed CR or PR from the first documented response to the date of documented disease progression or death. up to 24 months
Secondary Incidence and severity of adverse events [Safety and tolerability] Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities. up to 24 months
Secondary Quality of life (QLQ-OV28) up to 24 months
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