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

NCT03748186 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STRO-002-GM1
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 27

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002)

  Incidence of adverse events (AEs) observed across STRO-002 dose levels

  18 months

• Part 1: Define the recommended phase 2 dose (RP2D) of STRO-002

  Frequency of dose-limiting toxicity and exposure across STRO-002 dose levels

  18 months

• Part 1: Define the maximum tolerated dose (MTD) of STRO-002

  Frequency of dose-limiting toxicity and exposure across STRO-002 dose levels

  18 months

• Part 2: Evaluate preliminary anti-tumor activity (ovarian, Fallopian and primary peritoneal cancer patients)

  Objective response rate per RECIST 1.1

  24 months

• Part 2: Evaluate preliminary anti-tumor activity (endometrial cancer patients)

  Objective response rate per RECIST 1.1

  24 months

Secondary Outcomes (13)

• Part 1: Characterize the pharmacokinetics (PK) of STRO-002 by measuring the maximum plasma concentration (Cmax)

  18 months

• Part 1: Characterize the PK of STRO-002 by measuring the half-life (t1/2) of STRO-002

  18 months

• Part 1: Characterize the PK of STRO-002 measuring the total area under the concentration versus time curve from zero to infinity (AUCinf)

  18 months

• Part 1: Characterize the PK of STRO-002 by measuring the clearance (CL)

  18 months

• Part 1: Characterize the PK of STRO-002 by measuring the the steady state volume of distribution (Vss)

  18 months

Other Outcomes (1)

• Part 1: Preliminary assessment of the anti-tumor activity of STRO-002

  18 months

Study Arms (1)

STRO-002 treatment

EXPERIMENTAL

Dose Escalation: STRO-002 at increasing dose levels Dose Expansion: STRO-002 at 4.3 mg/kg and 5.2 mg/kg

Drug: STRO-002

Interventions

STRO-002 DRUG

intravenous antibody drug conjugate

STRO-002 treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients are required to have ovarian, fallopian, primary peritoneal or endometrial cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Measurable disease per RECIST 1.1
• ECOG performance status (0-1)
• Life expectancy \> 3 months
• Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)
• Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer
• Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma NOS)
• Relapsed and/or progressive disease
• 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.
• 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.

You may not qualify if:

• Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).
• Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).
• Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
• Platinum-refractory during frontline treatment (Cohorts A and C)
• Greater than 3 lines of prior treatment
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
• 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
• Metastatic central nervous system or meningeal disease
• Concurrent participation in another therapeutic treatment trial

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead

Study Sites (27)

Arizona Oncology - Tucson

Tucson, Arizona, 85711, United States

Location

UCLA Jonsson Comprehensive Cancer Center Clinical Research Unit

Los Angeles, California, 90095, United States

Location

Sutter Health- Palo Alto Medical Foundation

San Francisco, California, 94109, United States

Location

Rocky Mountain Cancer Center

Aurora, Colorado, 80012, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Miami Cancer Institue, Baptist Health South Florida

Miami, Florida, 33176, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Augusta Oncology

Augusta, Georgia, 30912, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Maryland Oncology Hematology

Rockville, Maryland, 20850, United States

Location

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

Ohio State University, James Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Cancer Care Northwest-South Spokane

Spokane, Washington, 99204, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Vall d'Hebron Institut d'Oncologia

Barcelona, 08035, Spain

Location

Clínica Universidad de Navarra -Madrid

Madrid, 28027, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, 28050, Spain

Location

Related Publications (1)

• 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.

  PMID: 36459691 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Carcinoma, Endometrioid; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

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; Uterine Neoplasms; Uterine Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a modified 3+3 dose escalation study with a dose expansion. Dose escalation is in advanced ovarian cancer patients with relapsed or refractory disease to standard approved therapy. Dose expansion includes 2 cancer populations, ovarian cancer and endometrial cancer. The ovarian cancer expansion cohorts are Cohort A and Cohort C. Cohort A is a dose ranging design with randomization into 2 dose levels of STRO-002, 4.3 mg/kg and 5.2mg/kg. Cohort C is a single dose cohort design, STRO-002 5.2 mg/kg with prophylactic pegfilgrastim. Dose expansion in endometrial cancer (Cohort B) is a single dose cohort design, STRO-002 5.2 mg/kg. Endometrial subjects with prior pelvic irradiation will start treatment of STRO-002 at 4.3 mg/kg with step up to 5.2 mg/kg.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 20, 2018
• Study Start: February 1, 2019
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); US (23)