Experimental ovarian cancer drug combo studied in early trial
NCT ID NCT05200364
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested a new drug called STRO-002 combined with Avastin (bevacizumab) in 58 people with advanced ovarian, fallopian tube, or primary peritoneal cancer. The main goals were to check safety and find the right dose. The study was terminated early, so while it gathered some safety data, it does not yet show whether the combination works better than existing treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STRO-002 (an antibody-drug conjugate) combined with bevacizumab (Avastin)
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced ovarian cancer that has stopped responding to other therapies.
- What could go wrong
- This was a very early (Phase 1) trial focused on safety and dosing, not effectiveness. The study was terminated early, so results are limited and may not lead to a standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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58 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years. 2. ECOG 0-1 3. Life expectancy \> 3 months 4. High Grade serous epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer with pathology report documentation of tumor type. 5. At least one measurable target lesion per RECIST v1.1. 6. Tumor tissue for FolRα expression testing prior to enrollment. 1. For dose escalation: tissue may be from either archival tumor tissue or from a biopsy performed during screening. 2. For dose expansion part of the study, tissue from both archival tumor tissue and a biopsy performed during screening is required. 7. Adequate bone marrow function defined as: 1. Absolute neutrophil count (ANC) ≥1500/μL 2. Hemoglobin ≥ 9g/dL 3. Platelet count ≥ 100 x 10\^3/μL 8. Adequate liver function defined as: 1. ALT and AST \< 2.5 x ULN 2. ALP \< 2.5 x ULN 3. Bilirubin \< 1.5 x ULN 9. 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: 10. Relapsed and/or PD on last treatment regimen and one of the following: 1. Primary Platinum refractory and received no more than 1 prior regimen 2. Primary platinum resistant and received no more than 4 prior regimens 3. 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: 11. Relapsed and/or PD on last treatment regimen and one of the following: 1. Platinum resistant and received no more than 4 prior regimens 2. 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 Exclusion Criteria: 1. Low grade ovarian carcinoma (Grade 1). 2. Clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas, endometrial leiomyosarcoma, and endometrial stromal sarcomas. 3. Prior treatment with an ADC with a tubulin inhibitor warhead. 4. Prior treatment with other FolRα targeting agents unless approved by a Sutro medical monitor or designee. 5. 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). 6. Greater than 4 prior lines of treatment (\> 1 prior if primary platinum refractory). 7. Any prior toxicity that required permanent discontinuation of bevacizumab or other contraindication to receive bevacizumab per institutional guidelines. 8. Previous solid organ transplantation. 9. Current signs/symptoms of bowel obstruction and/or signs/symptoms of or bowel obstruction within 3 months of initiation of study treatment. 10. Grade ≥2 toxicity from prior anticancer therapy with the exception of Grade 2 alopecia or Grade 2 neuropathy. 11. Uncontrolled hypertension 12. Sensory or motor neuropathy Grade \> 1 at screening prior to initiation of study treatment. 13. Potentially fatal concurrent or recent malignancy. Subjects with past or current malignancy need to be discussed with the sponsor to determine eligibility. 14. Chronic or ongoing active infection requiring systemic treatment. 15. 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. 16. Clinically significant cardiac disease. 17. History or clinical signs of meningeal or active central nervous system involvement. 18. Known severe COPD or asthma 19. Active pneumonitis within 6 months of initiating study treatment. 20. History of stroke or history of significant cerebrovascular disease (i.e., transient ischemic attack) within 6 months of initiation of study treatment. 21. History of pulmonary embolism or any Grade 3 thromboembolic event within 6 months of initiation of study treatment. 22. Known human immunodeficiency virus seropositivity. 23. Active hepatitis B or hepatitis C and positive serology (unless due to vaccination or passive immunization due to immunoglobulin therapy) with the following exceptions: 1. Subject has had HCV but received antiviral treatment and shows no detectible HCV viral DNA for 6 months prior to screening 2. Subject has had HBV but is HBV surface antigen (HBsAg) and viral DNA negative at screening 3. Subject has had HBV but received antiviral treatment and have undetectable viral DNA for 6 months prior to screening 24. Concurrent participation in another therapeutic treatment trial 25. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease 26. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Tennessee Oncology
Nashville, Tennessee, 37203, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19017, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of South Florida,
Tampa, Florida, 33612, United States
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Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
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