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Ovarian CancerPhase 1NCT03748186

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

A Phase 1 study testing STRO-002 in people with Ovarian Cancer and Ovarian Carcinoma, run by Sutro Biopharma, Inc. at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Ovarian Carcinoma, Ovary Cancer
What is being tested?
STRO-002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
27 sitesin 2 countries
Study dates
1 Feb 2019to 4 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Fresh or archival tumor tissue samples

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States23 sites

  • Augusta Oncology

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267

  • Ohio State University, James Cancer Center

    Columbus, Ohio, 43210

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Prisma Health

    Greenville, South Carolina, 29605

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • UCLA Jonsson Comprehensive Cancer Center Clinical Research Unit

    Los Angeles, California, 90095

  • Miami Cancer Institue, Baptist Health South Florida

    Miami, Florida, 33176

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale School of Medicine

    New Haven, Connecticut, 06520

  • NYU Langone Medical Center

    New York, New York, 10016

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Maryland Oncology Hematology

    Rockville, Maryland, 20850

  • Sutter Health- Palo Alto Medical Foundation

    San Francisco, California, 94109

  • Cancer Care Northwest-South Spokane

    Spokane, Washington, 99204

  • University of South Florida

    Tampa, Florida, 33606

  • Arizona Oncology - Tucson

    Tucson, Arizona, 85711

Other trials in United States

Spain4 sites

  • Vall d'Hebron Institut d'Oncologia

    Barcelona, 08035

  • Clínica Universidad de Navarra -Madrid

    Madrid, 28027

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

Other trials in Spain

About this study

Official title: A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody-Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers

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

Read the 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.

Being tested
STRO-002
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Endometrioid, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STRO-002Drug

    intravenous antibody drug conjugate

Study groups in NCT03748186
Study groupRoleWhat they receive
STRO-002 treatmentExperimentalDose Escalation: STRO-002 at increasing dose levels Dose Expansion: STRO-002 at 4.3 mg/kg and 5.2 mg/kg
Receives: Drug: STRO-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 months

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

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

    Measured: 18 months

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

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

    Measured: 18 months

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

    Objective response rate per RECIST 1.1

    Measured: 24 months

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

    Objective response rate per RECIST 1.1

    Measured: 24 months

Secondary outcomes (13)

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

    Measurement of maximum plasma concentration after the administration of STRO-002

    Measured: 18 months

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

    Measurement of terminal half-life of STRO-002 after the administration of STRO-002

    Measured: 18 months

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

    Measurement of AUC to infinity (AUCinf)

    Measured: 18 months

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

    Measurement of total body clearance

    Measured: 18 months

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

    Measurement of steady state volume of distribution

    Measured: 18 months

  6. Part 1: Assess the formulation of anti-drug antibodies to STRO-002

    Circulating anti-drug antibodies (ADAs) formed to STRO-002

    Measured: 18 months

  7. Part 2: Further evaluate the incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002)

    Number of patients with abnormal laboratory values and/or adverse events related to STRO-002 treatment

    Measured: 24 months

  8. Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of duration of response (DOR) in patients treated with STRO-002

    Duration of response per RECIST 1.1

    Measured: 24 months

  9. Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of progression-free survival (PFS) in patients treated with STRO-002

    Progression-free survival per RECIST 1.1

    Measured: 24 months

  10. Part 2: Evaluate preliminary effect of STRO-002 treatment on CA-125 levels

    Response assessment based on the Gynecologic Cancer Intergroup (GCIG) criteria

    Measured: 24 months

  11. Part 2: Characterize the PK of STRO-002 by measuring the maximum plasma concentration (Cmax)

    Measurement of maximum plasma concentration (Cmax) after the administration of STRO-002

    Measured: 24 months

  12. Part 2: Characterize the PK of STRO-002 by measuring the area under the plasma concentration versus time curve (AUC)

    Measurement of AUC to infinity (AUC inf)

    Measured: 24 months

  13. Part 2: Characterize the PK of STRO-002 by measuring the clearance (CL)

    Measurement of total body clearance

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start1 Feb 2019
  3. Primary completion4 Jun 2024
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748186
Sponsor's protocol ID
STRO-002-GM1
Status last verified
Jan 2025
First submitted
13 Nov 2018
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36459691

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STRO-002 in people with Ovarian Cancer and Ovarian Carcinoma, run by Sutro Biopharma, Inc. at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002) (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748186, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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