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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

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ClinicalTrials.gov Identifier: NCT05870748
Recruitment Status : Not yet recruiting
First Posted : May 23, 2023
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Sutro Biopharma, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Platinum-resistant Ovarian Cancer Drug: Luveltamab tazevibulin Drug: Pegfilgrastim Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : May 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Luveltamab tazevibulin dose cohort A
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
antibody-drug conjugate
Other Name: STRO-002

Drug: Pegfilgrastim
pegylated G-CSF
Other Name: Neulasta
Experimental: Part 1: Luveltamab tazevibulin dose cohort B
4.3 mg/kg q3w
 Drug: Luveltamab tazevibulin
antibody-drug conjugate
Other Name: STRO-002


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 24 months ]
    Best response of complete response (CR) or partial response (PR) per RECIST 1.1


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: up to 24 months ]
    Confirmed CR or PR from the first documented response to the date of documented disease progression or death

  2. Progression Free Survival (PFS) [ Time Frame: up to 24 months ]
    time between the date of first dose and the first date of documented progression or death

  3. Overall Survival (OS) [ Time Frame: up to 24 months ]
    time between date of first dose and date of death due to an cause or end of study

  4. Safety and tolerabilty [ Time Frame: up to 24 months ]
    incidence and severity of adverse events (AEs) and clinical laboratory abnormalities per NCI CTCAE v5.0


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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. Must have received prior bevacizumab for treatment of ovarian cancer or have a documented contraindication to receive bevacizumab
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05870748


Contacts
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Contact: Craig Berman, MD 650-801-6417 STRO-002ClinDev@sutrobio.com

Sponsors and Collaborators
Sutro Biopharma, Inc.
More Information
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Responsible Party: Sutro Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT05870748    
Other Study ID Numbers: STRO-002-GM3
First Posted: May 23, 2023    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sutro Biopharma, Inc.:
FOLR1
FolRα
FRα
folate receptor alpha
 antibody drug conjugate
Luveltamab tazevibulin
STRO-002
luvelta
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases