Phase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
intravenous antibody drug conjugate
anti-VEGF agent
University of South Florida,
Tampa, Florida, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
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.
Time frame: From baseline through end of study (approximately 24 months)
Part 1 - Determine the recommended phase 2 dose (RP2D) of STRO-002/bevacizumab
Frequency of DLTs across STRO-002 dose levels
Time frame: From baseline through end of study (approximately 24 months)
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
Time frame: From baseline through end of study (approximately 24 months)
Part 1 - Characterize the PK of STRO-002 by measuring the area under the plasma concentration versus time curve (AUC)
Measurement of AUC
Time frame: From baseline through end of study (approximately 24 months)
Part 1 - Assess the formation of anti-drug antibodies (ADAs) to STRO-002 when administered with bevacizumab.
Circulating ADAs formed to STRO-002
Time frame: From baseline through end of study (approximately 24 months)
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Virginia Cancer Specialists
Fairfax, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States