TERMINATED

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

Conditions

Ovarian Cancer Ovarian Carcinoma Ovary Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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)

Quick Facts

Study Start:2022-03-22

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05200364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Arturo Molina, MD

STUDY_CHAIR

Sutro Biopharma

Study Locations (Sites)

University of South Florida,

Tampa, Florida, 33612

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19017

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Tennessee Oncology

Nashville, Tennessee, 37203

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Sutro Biopharma, Inc.

Arturo Molina, MD, STUDY_CHAIR, Sutro Biopharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-22

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2022-03-22

Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

Ovarian Cancer
Ovarian Carcinoma
Ovary Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma