Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

Last updated: January 14, 2025
Sponsor: Sutro Biopharma, Inc.
Overall Status: Completed

Phase

1

Condition

Ovarian Cancer

Endometriosis

Ovarian Cysts

Treatment

STRO-002

Clinical Study ID

NCT03748186
STRO-002-GM1
  • Ages > 18
  • Female

Study Summary

Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-002 given intravenously every 3 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Measurable disease per RECIST 1.1

  3. ECOG performance status (0-1)

  4. Life expectancy > 3 months

  5. Pathological confirmation of disease under study (historical information, diagnosis,pathology report, etc)

  6. Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer orprimary peritoneal cancer

  7. Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixedepithelial carcinoma; or adenocarcinoma NOS)

  8. Relapsed and/or progressive disease

  9. Dose Expansion Cohorts A and C (Ovarian Cancer):

  • Platinum resistant and received 1-3 prior regimens or
  • Platinum sensitive and either:
  • Progressed after 2 prior lines of platinum therapy (regardless of platinumstatus)and received 2-3 prior regimens or
  • Progressed after 1 line of platinum therapy and 1 line of non-platinumtherapy and received a total of 2-3 prior regimens if contraindicated toreceive second platinum regimen.
  1. Dose Expansion Cohort B (Endometrial Cancer):
  • Relapsed or progression after at least 1 platinum-based chemotherapyregimen or 1 immunotherapy-based regimen but not to exceed more than 3prior regimens.
  1. Fresh or archival tumor tissue samples

Exclusion

Exclusion Criteria:

  1. Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovariancarcinomas (Cohort A).

  2. Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).

  3. Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines

  4. Platinum-refractory during frontline treatment (Cohorts A and C)

  5. Greater than 3 lines of prior treatment

  6. History of severe allergic or anaphylactic reactions to monoclonal antibody therapyor to antibody-related fusion protein treatment

  7. Preexisting clinically significant ocular disorders, clinically significantpre-exisiting ocular disorders, severe chronic obstructive pulmonary disease orasthma, clinically significant cardiac or cerebrovascular disease, or othersignificant concurrent, uncontrolled medical condition

  8. Metastatic central nervous system or meningeal disease

  9. Concurrent participation in another therapeutic treatment trial

Study Design

Total Participants: 136
Treatment Group(s): 1
Primary Treatment: STRO-002
Phase: 1
Study Start date:
February 01, 2019
Estimated Completion Date:
June 04, 2024

Study Description

This study is a phase 1, open-label, multicenter, dose-escalation study with dose expansion to identify the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D) and to evaluate the safety, tolerability, and preliminary antitumor activity of STRO-002 in adult subjects with advanced epithelial ovarian cancer (EOC), including fallopian or primary peritoneal cancer, and endometrial cancer. Fallopian tube and primary peritoneal cancers are treated in the same manner as epithelial ovarian cancers and are thus included in this phase 1 study. Subjects enrolled in the study will be required to have progressive or recurrent disease after standard approved therapy as defined in the study eligibility criteria. The study has completed dose escalation and is currently in dose expansion, enrolling endometrial and ovarian cancer subjects.

All subjects enrolled on the study are required to have tumor tissue for determining folate receptor alpha (FolRα) expression levels, either from a prior surgery or tumor biopsy or from a biopsy performed during study screening. The testing for FolRα is done via an ICH assay. A minimum level of FolRα expression is required for enrollment for endometrial cancer but not for ovarian cancer.

Study drug, STRO-002, is administered by intravenous (IV) infusion on day 1 of 21-day cycles. Clinical evaluations and/or laboratory tests will be performed at a pre-specified schedule-weekly for cycles 1-4, and at the beginning of every cycle starting with cycle 5 as described in the schedule of assessments. Samples for PK analysis will occur at specific times on days 1, 8, and 15 of cycles 1 and 4, Day 1 of cycles 2, 3, and 5 and at the end of treatment (EOT) visit. The study requires imaging with a CT or MRI scan of the chest abdomen and pelvis at screening, every 6 weeks after enrollment for the first 18 weeks, then every 9 weeks, and at the end of treatment (EOT) visit. Additional X-rays may be required to confirm disease responses and per local institution standard of care.

Additional clinical evaluations and lab testing may occur at the discretion of the investigator.

Connect with a study center

  • Vall d'Hebron Institut d'Oncologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Clínica Universidad de Navarra -Madrid

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Arizona Oncology - Tucson

    Tucson, Arizona 85711
    United States

    Site Not Available

  • UCLA Jonsson Comprehensive Cancer Center Clinical Research Unit

    Los Angeles, California 90095
    United States

    Site Not Available

  • Sutter Health- Palo Alto Medical Foundation

    San Francisco, California 94109
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Miami Cancer Institue, Baptist Health South Florida

    Miami, Florida 33176
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Augusta Oncology

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Maryland Oncology Hematology

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Ohio State University, James Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Prisma Health

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Cancer Care Northwest-South Spokane

    Spokane, Washington 99204
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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