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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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 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 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 is a chemotherapy regimen approved for treatment of previously treated ovarian cancer. It stabilizes microtubules, inhibiting tumor cell replication.
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 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.
Arizona Oncology Associates, PC-Hope
Tucson, Arizona, United States
Sutter Health
Daly City, California, United States
Scripps Health
San Diego, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Health South Florida (BHSF) - Miami Cancer Institute
Miami, Florida, United States
Progression Free Survival (PFS)
time between the date of first dose and the first date of documented progression or death
Time frame: up to 24 months
Objective Response Rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1.
Time frame: up to 24 months
Overall Survival (OS)
Time between date of first dose and date of death due to an cause or end of study.
Time frame: up to 24 months
Duration of Response (DOR)
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Time frame: up to 24 months
Incidence and severity of adverse events [Safety and tolerability]
Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.
Time frame: up to 24 months
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.
Time frame: up to 24 months
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Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
USF Research & Innovation
Tampa, Florida, United States
Augusta University Medical Center
Augusta, Georgia, United States
Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
...and 53 more locations