Study QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conducted in two major parts which are further organized into two sub-parts. Part A Dose Escalation is a modified 3+3 with the first two cohorts consisting of one subject each based on the low clinical starting dose. Dose escalation in solid tumors (Part A1) will be followed by dose finding in multiple myeloma (Part A2). Part B consists of dose expansion in solid tumors (Part B1) and multiple myeloma (Part B2) using the recommended dose for expansion from Part A
Participants with Solid Tumors
Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid tumor (ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal (GI), lung, prostate, and breast cancer).
Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. Patients must have no available therapeutic options known to confer clinical benefit for their tumor type.
Participants with Multiple Myeloma
New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Pointes (TdP), including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG.
The use of concomitant medications that may significantly prolong the QT/QTc interval.
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80).
Single group
QXL138AM Injection every 2 weeks by IV Infusion
Biological/Vaccinemasked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a
Incidence of Adverse Events
Record all safety events during study including AEs, SAEs, DLTs, AESIs.
Measurement of maximum plasma concentration (Cmax) of QXL138AM
Measured from blood samples
Describe Anti-tumor activity
Indices of anti-tumor activity (using RECIST 1.1 for solid tumors) and International Myeloma Working Group \[IMWG\] Uniform Response Criteria for multiple myeloma) such as overall response rate (ORR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), minimal residual disease (MRD) and overall survival (OS) during treatment (Part B only)
Measurement of trough concentration (Ctrough) of QXL138AM
Measured from blood samples
Measurement of area under the serum concentration-time curve (AUC) of QXL138AM
Measured from blood samples
Measurement of Exploratory Biomarkers
Identify any correlation between CD138 expression in tumors and anti-tumor response and to characterize the changes in serum cytokine levels such as: IFN- , TNF-α, IL-6 and IL-2
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