Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma (NCT06582017) | Clinical Trial Compass
RecruitingPhase 1
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
United States100 participantsStarted 2024-08-28
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants with Solid Tumors
✓. Participants with Multiple Myeloma
Exclusion criteria
✕. 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.
✕. Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80).
✕. Female participant is lactating.
✕. Any other clinically significant comorbidities.
✕
What they're measuring
1
Incidence of Adverse Events
Timeframe: Throughout study - anticipated 3.5 years
. Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product.
✕. Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy)