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

NCT ID: NCT03748186

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2024-06-04

Brief Summary

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

Detailed 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.

Conditions

Ovarian Cancer; Ovarian Carcinoma; Ovary Cancer; Endometrial Cancer; Endometrioid Adenocarcinoma; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STRO-002 treatment

Dose Escalation: STRO-002 at increasing dose levels

Dose Expansion: STRO-002 at 4.3 mg/kg and 5.2 mg/kg

Group Type: EXPERIMENTAL

STRO-002

Intervention Type: DRUG

intravenous antibody drug conjugate

Interventions

STRO-002

intravenous antibody drug conjugate

Intervention Type: DRUG

Eligibility Criteria

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)

1. Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer

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

6. Relapsed and/or progressive disease

1. 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 platinum status)and received 2-3 prior regimens or
• Progressed after 1 line of platinum therapy and 1 line of non-platinum therapy and received a total of 2-3 prior regimens if contraindicated to receive second platinum regimen.

2. Dose Expansion Cohort B (Endometrial Cancer):

• Relapsed or progression after at least 1 platinum-based chemotherapy regimen or 1 immunotherapy-based regimen but not to exceed more than 3 prior regimens.

7. Fresh or archival tumor tissue samples

Exclusion Criteria

1. Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (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 therapy or to antibody-related fusion protein treatment

7. Preexisting clinically significant ocular disorders, clinically significant pre-exisiting ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition

8. Metastatic central nervous system or meningeal disease

9. Concurrent participation in another therapeutic treatment trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sutro Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Oncology - Tucson

Tucson, Arizona, United States

UCLA Jonsson Comprehensive Cancer Center Clinical Research Unit

Los Angeles, California, United States

Sutter Health- Palo Alto Medical Foundation

San Francisco, California, United States

Rocky Mountain Cancer Center

Aurora, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

Miami Cancer Institue, Baptist Health South Florida

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Augusta Oncology

Augusta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Maryland Oncology Hematology

Rockville, Maryland, United States

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

NYU Langone Medical Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Ohio State University, James Cancer Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Cancer Care Northwest-South Spokane

Spokane, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Vall d'Hebron Institut d'Oncologia

Barcelona, , Spain

Clínica Universidad de Navarra -Madrid

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, , Spain

Countries

United States; Spain

References

Li X, Zhou S, Abrahams CL, Krimm S, Smith J, Bajjuri K, Stephenson HT, Henningsen R, Hanson J, Heibeck TH, Calarese D, Tran C, Yin G, Stafford RL, Yam AY, Kline T, De Almeida VI, Sato AK, Lupher M, Bedard K, Hallam TJ. Discovery of STRO-002, a Novel Homogeneous ADC Targeting Folate Receptor Alpha, for the Treatment of Ovarian and Endometrial Cancers. Mol Cancer Ther. 2023 Feb 1;22(2):155-167. doi: 10.1158/1535-7163.MCT-22-0322.

Reference Type: DERIVED

PMID: 36459691 (View on PubMed)

Other Identifiers

STRO-002-GM1

Identifier Type: -

Identifier Source: org_study_id