Status:
TERMINATED
A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer
Lead Sponsor:
Sutro Biopharma, Inc.
Conditions:
Ovarian Cancer
Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab.
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 refractor...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05200364
Start Date
March 22 2022
End Date
June 1 2025
Last Update
September 22 2025
Active Locations (6)
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1
University of South Florida,
Tampa, Florida, United States, 33612
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19017
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Tennessee Oncology
Nashville, Tennessee, United States, 37203