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Ovarian CancerPhase 1NCT05200364

A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer

A Phase 1 study testing STRO-002 and Bevacizumab in people with Ovarian Cancer and Ovarian Carcinoma, run by Sutro Biopharma, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab. 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 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
6 sitesUnited States
Study dates
22 Mar 2022to 1 Jun 2025
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.
  • ECOG 0-1
  • Life expectancy > 3 months
  • High Grade serous epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer with pathology report documentation of tumor type.
  • At least one measurable target lesion per RECIST v1.1.
  • Tumor tissue for FolRα expression testing prior to enrollment.
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  • For dose escalation: tissue may be from either archival tumor tissue or from a biopsy performed during screening.
  • For dose expansion part of the study, tissue from both archival tumor tissue and a biopsy performed during screening is required.
  • Adequate bone marrow function defined as:
  • Absolute neutrophil count (ANC) ≥1500/μL
  • Hemoglobin ≥ 9g/dL
  • Platelet count ≥ 100 x 10^3/μL
  • Adequate liver function defined as:
  • ALT and AST < 2.5 x ULN
  • ALP < 2.5 x ULN
  • Bilirubin < 1.5 x ULN
  • Adequate renal function defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) > 40 mL/min.
  • Subjects enrolling into Dose Escalation must also meet the following inclusion criteria:
  • Relapsed and/or PD on last treatment regimen and one of the following:
  • Primary Platinum refractory and received no more than 1 prior regimen
  • Primary platinum resistant and received no more than 4 prior regimens
  • Platinum sensitive and all of the following:
  • received at least 2 platinum-based therapies or received 1 platinum and 1 non-platinum based therapy (if unable to receive a second platinum regimen due to toxicity) or received at least 1 platinum-based therapy (if the regimen contained a PARP inhibitor given as maintenance treatment)
  • received no more than 1 additional regimen after becoming platinum resistant
  • received no more than 4 prior regimens
  • Subjects enrolling into Part 2, Dose Expansion must also meet the following inclusion criteria:
  • Relapsed and/or PD on last treatment regimen and one of the following:
  • Platinum resistant and received no more than 4 prior regimens
  • Platinum sensitive and
  • received at least 2 platinum-based therapies or received 1 platinum and 1 non-platinum based therapy (if unable to receive a second platinum regimen due to toxicity) or received at least 1 platinum-based therapy (if the regimen contained a PARP inhibitor given as maintenance treatment)
  • received no more than 1 additional regimen after becoming platinum resistant
  • received no more than 4 prior regimens

Who cannot join

  • Low grade ovarian carcinoma (Grade 1).
  • Clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas, endometrial leiomyosarcoma, and endometrial stromal sarcomas.
  • Prior treatment with an ADC with a tubulin inhibitor warhead.
  • Prior treatment with other FolRα targeting agents unless approved by a Sutro medical monitor or designee.
  • Subjects who are primary platinum-refractory during frontline treatment are excluded from the Expansion Cohort (Allowed in Dose Escalation if no more than 1 prior regimen).
  • Greater than 4 prior lines of treatment (> 1 prior if primary platinum refractory).
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  • Any prior toxicity that required permanent discontinuation of bevacizumab or other contraindication to receive bevacizumab per institutional guidelines.
  • Previous solid organ transplantation.
  • Current signs/symptoms of bowel obstruction and/or signs/symptoms of or bowel obstruction within 3 months of initiation of study treatment.
  • Grade ≥2 toxicity from prior anticancer therapy with the exception of Grade 2 alopecia or Grade 2 neuropathy.
  • Uncontrolled hypertension
  • Sensory or motor neuropathy Grade > 1 at screening prior to initiation of study treatment.
  • Potentially fatal concurrent or recent malignancy. Subjects with past or current malignancy need to be discussed with the sponsor to determine eligibility.
  • Chronic or ongoing active infection requiring systemic treatment.
  • Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Physiologic replacement and use of topical or inhaled corticosteroids are allowed. Dexamethasone may be used to treat chemotherapy induced nausea per institutional guidelines.
  • Clinically significant cardiac disease.
  • History or clinical signs of meningeal or active central nervous system involvement.
  • Known severe COPD or asthma
  • Active pneumonitis within 6 months of initiating study treatment.
  • History of stroke or history of significant cerebrovascular disease (i.e., transient ischemic attack) within 6 months of initiation of study treatment.
  • History of pulmonary embolism or any Grade 3 thromboembolic event within 6 months of initiation of study treatment.
  • Known human immunodeficiency virus seropositivity.
  • Active hepatitis B or hepatitis C and positive serology (unless due to vaccination or passive immunization due to immunoglobulin therapy) with the following exceptions:
  • Subject has had HCV but received antiviral treatment and shows no detectible HCV viral DNA for 6 months prior to screening
  • Subject has had HBV but is HBV surface antigen (HBsAg) and viral DNA negative at screening
  • Subject has had HBV but received antiviral treatment and have undetectable viral DNA for 6 months prior to screening
  • Concurrent participation in another therapeutic treatment trial
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
  • Females who are pregnant or breastfeeding, and all women of childbearing potential unwilling to use adequate barrier contraception while on treatment and for 16 weeks after last dose of STRO-002/bevacizumab and 6 months after the last dose of bevacizumab.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19017

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of South Florida,

    Tampa, Florida, 33612

Other trials in United States

About this study

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

Phase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab.

Read the detailed description

This study is a Phase 1, open-label, multicenter, dose escalation study to assess preliminary efficacy for STRO-002 combined with bevacizumab in patients with advanced ovarian cancer that is refractory or has relapsed after standard available therapy. Fallopian tube and primary peritoneal cancers are treated in the same manner as epithelial ovarian cancers and are thus included in this study.

The dosing regimen will include bevacizumab administered at the labeled dose of 15 mg/kg IV q 3 weeks given together with STRO-002 at increasing dose levels administered IV q 3 weeks. The RP2D of STRO-002 given with bevacizumab 15 mg/kg q 3 weeks will be determined by dose escalation.

Dose expansion will enroll approximately 40 subjects with advanced relapsed ovarian cancer treated with STRO-002 plus bevacizumab at the RP2D determined in dose escalation. Subjects in the dose expansion portion of the study will be required at screening to submit both archival tumor tissue (if available and available tissue has adequate tumor) and tumor tissue from a biopsy done during screening to the central laboratory for analysis of FOLRα expression, both prior to enrollment in the study.

Being tested
STRO-002, Bevacizumab
Medical subject headings
Ovarian Neoplasms, 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

  • BevacizumabDrug

    Also called Avastin

    anti-VEGF agent

Study groups in NCT05200364
Study groupRoleWhat they receive
Experimental :STRO-002 treatment in combination with BevacizumabExperimentalDose Escalation: STRO-002 at increasing dose levels plus bevacizumab at 15 mg/kg Dose Expansion: STRO-002 at RP2D plus bevacizumab at 15 mg/kg
Receives: Drug: STRO-002; Drug: Bevacizumab

What is being measured

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

  1. Part 1 - Safety and tolerability of STRO-002/bevacizumab as a combination therapy

    Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities observed across STRO-002/bevacizumab dose levels. Incidence of dose-limiting toxicities (DLTs) through Day 1-21 following administration of each initial STRO-002/bevacizumab dose.

    Measured: From baseline through end of study (approximately 24 months)

  2. Part 1 - Determine the recommended phase 2 dose (RP2D) of STRO-002/bevacizumab

    Frequency of DLTs across STRO-002 dose levels

    Measured: From baseline through end of study (approximately 24 months)

Secondary outcomes (3)

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

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

    Measured: From baseline through end of study (approximately 24 months)

  2. Part 1 - Characterize the PK of STRO-002 by measuring the area under the plasma concentration versus time curve (AUC)

    Measurement of AUC

    Measured: From baseline through end of study (approximately 24 months)

  3. Part 1 - Assess the formation of anti-drug antibodies (ADAs) to STRO-002 when administered with bevacizumab.

    Circulating ADAs formed to STRO-002

    Measured: From baseline through end of study (approximately 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 Jan 2022
  2. Study start22 Mar 2022
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Why it stopped: Terminated Early

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 designed as a 3+3 dose escalation/de-escalation of STRO-002 given in combination with the labeled dose of bevacizumab. The patient population is relapsed ovarian cancer and the study treatment is the combination of STRO-002 plus bevacizumab. This study will be conducted in 2 parts, dose escalation and dose expansion.
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05200364
Sponsor's protocol ID
STRO-002-GM2
Status last verified
Nov 2024
First submitted
19 Dec 2021
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
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 and Bevacizumab in people with Ovarian Cancer and Ovarian Carcinoma, run by Sutro Biopharma, Inc. at 6 sites in United States.

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 32 inclusion and 29 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: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 was stopped early (reason given: Terminated Early). Results are not available in the source record.

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 - Safety and tolerability of STRO-002/bevacizumab as a combination therapy (time frame: From baseline through end of study (approximately 24 months)). The study lists 2 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 NCT05200364, 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 22 Sep 2025.

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