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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

Primary Purpose

Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Luveltamab tazevibulin
Pegfilgrastim
Sponsored by
Sutro Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring FOLR1, FolRα, FRα, folate receptor alpha, antibody drug conjugate, Luveltamab tazevibulin, STRO-002, luvelta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • MedStar Washington Hospital CenterRecruiting
  • USF Research & InnovationRecruiting
  • Optimum Clinical Research GroupRecruiting
  • NYU Langone HealthRecruiting
  • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer CenterRecruiting
  • Lancaster General HospitalRecruiting
  • Chris O'Brien LifehouseRecruiting
  • Prince of Wales HospitalRecruiting
  • Westmead HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Luveltamab tazevibulin dose cohort A

Part 1: Luveltamab tazevibulin dose cohort B

Arm Description

5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for cycle 3 onwards

4.3 mg/kg q3w

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1

Secondary Outcome Measures

Duration of Response (DOR)
Confirmed CR or PR from the first documented response to the date of documented disease progression or death
Progression Free Survival (PFS)
time between the date of first dose and the first date of documented progression or death
Overall Survival (OS)
time between date of first dose and date of death due to an cause or end of study
Safety and tolerabilty
incidence and severity of adverse events (AEs) and clinical laboratory abnormalities per NCI CTCAE v5.0

Full Information

First Posted
May 12, 2023
Last Updated
October 10, 2023
Sponsor
Sutro Biopharma, Inc.
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT05870748
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sutro Biopharma, Inc.
Collaborators
Gynecologic Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer
Keywords
FOLR1, FolRα, FRα, folate receptor alpha, antibody drug conjugate, Luveltamab tazevibulin, STRO-002, luvelta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Luveltamab tazevibulin dose cohort A
Arm Type
Experimental
Arm Description
5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for cycle 3 onwards
Arm Title
Part 1: Luveltamab tazevibulin dose cohort B
Arm Type
Experimental
Arm Description
4.3 mg/kg q3w
Intervention Type
Drug
Intervention Name(s)
Luveltamab tazevibulin
Other Intervention Name(s)
STRO-002
Intervention Description
antibody-drug conjugate
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta
Intervention Description
pegylated G-CSF
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
Confirmed CR or PR from the first documented response to the date of documented disease progression or death
Time Frame
up to 24 months
Title
Progression Free Survival (PFS)
Description
time between the date of first dose and the first date of documented progression or death
Time Frame
up to 24 months
Title
Overall Survival (OS)
Description
time between date of first dose and date of death due to an cause or end of study
Time Frame
up to 24 months
Title
Safety and tolerabilty
Description
incidence and severity of adverse events (AEs) and clinical laboratory abnormalities per NCI CTCAE v5.0
Time Frame
up to 24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Berman, MD
Phone
650-801-6417
Email
STRO-002ClinDev@sutrobio.com
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiwot Guebre-Xabiher
Phone
202-877-9386
Email
Hiwot.Guebre-Xabiher@medstar.net
First Name & Middle Initial & Last Name & Degree
Ebony Hoskins, MD
Facility Name
USF Research & Innovation
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Murillo
Phone
813-844-8221
Email
kmurillo@tgh.org
First Name & Middle Initial & Last Name & Degree
Matthew Anderson, MD
Facility Name
Optimum Clinical Research Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Chalamidas
Phone
505-372-1968
Email
kchalamidas@optimumresearchabq.com
First Name & Middle Initial & Last Name & Degree
Karen Finkelstein, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Kallas
Phone
212-998-1212
Email
Keith.Kallas@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Bhavana Pothuri, MD
Facility Name
Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Marangoni, PhD
Phone
918-505-3200
Ext
4195
Email
Daniel.Marangoni@ocsri.org
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krista Budzik
Phone
717-544-0511
Email
Krista.Budzik@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Bethany Bustamante, MD
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo Zhang
Phone
+61 2 8514 0659
Email
shirley.zhang@lh.org.au
First Name & Middle Initial & Last Name & Degree
Michelle Harrison
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Cet
Phone
61293825324
Email
Umuhan.Cet@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Yeh Chen Lee
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Campbell
Phone
0419 859 255
Email
Kate.Campbell1@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Bo Gao

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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