REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

Study Overview
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Brief Summary
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A Phase 2 study to investigate the efficacy and safety of luveltamab tazevibulin in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

Detailed Description
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This is a multicenter, international, open-label, 2-part Phase 2 study designed to assess the efficacy and safety of luveltamab tazevibulin in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1. Part 1 will consist of 2 dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to optimize the dosing regimen. Part 2 will further evaluate the efficacy and safety of the selected dosing regimen. Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.

Official Title
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REFRaME-O1: A Phase 2 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

Conditions
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Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer

Intervention / Treatment
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* Drug: Luveltamab tazevibulin
* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Must have received prior bevacizumab for treatment of ovarian cancer or have a documented contraindication to receive bevacizumab At least 1 measurable target lesion per RECIST v1.1 Adequate organ function Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Luveltamab tazevibulin dose cohort A<br>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<br>* antibody-drug conjugate<br>* Other names: STRO-002;Drug: Pegfilgrastim<br>* pegylated G-CSF<br>* Other names: Neulasta;|
| Experimental: Part 1: Luveltamab tazevibulin dose cohort B<br>4.3 mg/kg q3w | Drug: Luveltamab tazevibulin<br>* antibody-drug conjugate<br>* Other names: STRO-002;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Best response of complete response (CR) or partial response (PR) per RECIST 1.1 | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Progression Free Survival (PFS) | time between the date of first dose and the first date of documented progression or death | 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 | up to 24 months | 
| Safety and tolerabilty | incidence and severity of adverse events (AEs) and clinical laboratory abnormalities per NCI CTCAE v5.0 | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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luvelta, FOLR1, FolRα, FRα, folate receptor alpha, antibody drug conjugate, Luveltamab tazevibulin, STRO-002