REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

ClinicalTrials.gov processed this data on August 27, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified April 2024 by Sutro Biopharma, Inc., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group (APGOT)

Sponsor

Sutro Biopharma, Inc.

Information Provided by (Responsible Party)

Sutro Biopharma, Inc.

Clinicaltrials.gov Identifier

NCT05870748
Other Study ID Numbers: STRO-002-GM3
First Submitted: May 12, 2023
First Posted: May 23, 2023
Last Update Posted: August 29, 2024
Last Verified: April 2024
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Platinum-resistant Ovarian Cancer
  • Drug: Luveltamab tazevibulin
  • Drug: Pegfilgrastim
  • Drug: Gemcitabine
  • Drug: Paclitaxel
  • Drug: Pegylated liposomal doxorubicin
  • Drug: Topotecan

Study Design

Study TypeInterventional
Anticipated Enrollment600 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleREFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)
Study Start DateJuly 12, 2023
Anticipated Primary Completion DateAugust 2027
Anticipated Study Completion DateFebruary 2028

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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
    • 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.
  • Drug: Pegfilgrastim
    • Luveltamab tazevibulin dose Cohort B
      • 4.3 mg/kg q3w
    • 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.
    • Part 2: IC Chemotherapy
      • Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 q4w or 1000mg/m2 on Days 1 and 8 q3w

        Paclitaxel 80 mg/m2 on Days 1, 8, and 15 q4w

        Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 q4w

        Topotecan 4.0 mg/m2on Day 1, 8, and 15 q4w or 1.25 mg/m2 on Days 1 - 5 q3w
    • Drug: Gemcitabine
      • Drug: Paclitaxel
        • Drug: Pegylated liposomal doxorubicin
          • Drug: Topotecan

            Outcome Measures

            Primary Outcome Measures

            1. Progression Free Survival (PFS) [up to 24 months]
              time between the date of first dose and the first date of documented progression or death
            2. Objective Response Rate (ORR) [up to 24 months]
              Best response of complete response (CR) or partial response (PR) per RECIST 1.1.

            Secondary Outcome Measures

            1. Overall Survival (OS) [up to 24 months]
              Time between date of first dose and date of death due to an cause or end of study.
            2. Duration of Response (DOR) [up to 24 months]
              Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
            3. Incidence and severity of adverse events [Safety and tolerability] [up to 24 months]
              Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.
            4. Quality of life (QLQ-OV28) [up to 24 months]
              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.

            Eligibility Criteria

            Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
            Sexes Eligible for Study Female
            Accepts Healthy Volunteers No
            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
            • Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
            • 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

            Contacts and Locations

            Sponsors and Collaborators Sutro Biopharma, Inc., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
            GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
            Locations
            • Arizona Oncology Associates, PC-Hope | Tucson, Arizona, United States, 85711
            • Sutter Health | Daly City, California, United States, 94015
            • MedStar Washington Hospital Center | Washington, District of Columbia, United States, 20010
            • Baptist Health South Florida (BHSF) - Miami Cancer Institute | Miami, Florida, United States, 33176
            • USF Research & Innovation | Tampa, Florida, United States, 33612
            • Sinai Hospital of Baltimore | Baltimore, Maryland, United States, 21215
            • University of Massachusetts Chan Medical School | Worcester, Massachusetts, United States, 01655
            • Minnesota Oncology Hematology | Minneapolis, Minnesota, United States, 55404
            • Nebraska Methodist Hospital | Omaha, Nebraska, United States, 68114
            • Optimum Clinical Research Group | Albuquerque, New Mexico, United States, 87109
            • NYU Langone Health | New York, New York, United States, 10016
            • Good Samaritan Hospital Medical Center | West Islip, New York, United States, 11795
            • University of Cincinnati Medical Center | Cincinnati, Ohio, United States, 45219
            • Ohio State University Center | Columbus, Ohio, United States, 43210
            • Kettering Health | Kettering, Ohio, United States, 45429
            • Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center | Tulsa, Oklahoma, United States, 74146
            • Oncology Associates of Oregon, PC | Eugene, Oregon, United States, 97401
            • Providence Gynecologic Oncology Clinic | Portland, Oregon, United States, 97213-2933
            • Lancaster General Hospital | Lancaster, Pennsylvania, United States, 17602
            • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, United States, 19107
            • Texas Oncology | Dallas, Texas, United States, 75231
            • Texas Oncology-DFW | Dallas, Texas, United States, 75246
            • Texas Oncology-San Antonio | San Antonio, Texas, United States, 78240
            • Texas Oncology - The Woodlands | The Woodlands, Texas, United States, 77380
            • Virginia Cancer Specialists | Fairfax, Virginia, United States, 22031
            • Chris O'Brien Lifehouse | Camperdown, New South Wales, Australia, 2050
            • Prince of Wales Hospital | Randwick, New South Wales, Australia, 2031
            • Westmead Hospital | Westmead, New South Wales, Australia, 2145
            • McGill University Health Centere (MUHC)-Glen Site | Montréal, Quebec, Canada, H4A 3J1
            • Princess Margaret Cancer Center | Toronto, Canada, M5G 1X6
            • Sheba Medical Center | Ramat Gan, Israel, 52621
            • Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
            • Keimyung University Dongsan Hospital | Daegu, Korea, Republic of, 42061
            • National Cancer Center | Gyeonggi-do, Korea, Republic of, 10408
            • Gachon University Gil Hospital | Incheon, Korea, Republic of, 21565
            • Yonsei University, Severance Hospital | Seoul, Korea, Republic of, 03722
            • Health New Zealand - Te Whatu Ora Capital, Coast, and Hutt Valley - Wellington Regional Hospital | Newtown, Wellington, New Zealand, 6021
            • Curie Centre, Oncology centre | Novena, Singapore, 329563
            • National Cancer Center Singapore | Singapore, Singapore, 168583

            More Information

            Additional Relevant MeSH Terms

            • 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