SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study.
Study SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with either PLD or MIRV in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Patients will be appropriate for combination therapy for their next line of therapy. For the SL-172154 + MIRV cohort, patients' tumors must be positive (defined as PS2+ ≥ 25%) for folate receptor alpha (FRα) as defined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay. The first portion of the study will evaluate the safety of increasing dose levels of SL-172154 in combination with either PLD or MIRV and establish a combination dose for both regimens to be further evaluated in two dose expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
University of Arkansas for Medical sciences
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Robert H.Lurie ComprehensiveCancer Center, Northwestern University
Chicago, Illinois, United States
START Midwest
Grand Rapids, Michigan, United States
Stephenson Cancer Center, OU Health/ Sarah Cannon Research Institute
Oklahoma City, Oklahoma, United States
BC Cancer Center
Vancouver, British Columbia, Canada
University health Network (UHN)-University of Toronto
Toronto, Ontario, Canada
McGill University Health Care
Montreal, Quebec, Canada
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic de Barcelona Servicio de Oncología, Esc. 2, Planta 5 dcha
Barcelona, Catalonia, Spain
...and 11 more locations
Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab
Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts
Time frame: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab
Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects"
Time frame: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
Time frame: approximately 24 months
Immunogenicity to SL-172154
Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline
Time frame: approximately 24 months
Immunogenicity to MIRV
Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline
Time frame: approximately 24 months
Maximum Serum Concentration (Cmax) of SL-172154
The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses
Time frame: C1D8, C1D15, C2D8
Area Under the Serum Concentration-time Curve (AUC) of SL-172154
The AUC is the area under the serum concentration time curve of SL-172154 following single and multiple doses
Time frame: C1D8, C1D15 and C2D8
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses
Time frame: C1D8, C1D15 and C2D8
Maximum Serum Concentration (Cmax) of MIRV
The Cmax is the maximum observed serum concentration of MIRV following single and multiple doses
Time frame: Day 1 of each cycle, pre-dose and end of infusion (EOI)
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
The Cmax is the maximum observed serum concentration of Total Antibody (MIRV) following single and multiple doses
Time frame: Day 1 of each cycle, pre-dose and end of infusion (EOI)
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
The Cmax is the maximum observed serum concentration of DM4 Payload and S-Methyl DM4 payload following single and multiple doses
Time frame: Day 1 of each cycle, pre-dose and end of infusion (EOI)
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