Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
NCT Number: NCT06582017
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Ovarian Cancer|Pancreas Cancer|Urothelial Carcinoma|Renal Cell Carcinoma|Hepatocellular Carcinoma|Gastrointestinal Cancer|Lung Cancer|Prostate Cancer|Breast Cancer
Interventions: BIOLOGICAL: QXL138AM Injection every 2 weeks by IV Infusion
Sponsor: Nammi Therapeutics Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2028-05-30
Locations: University of Southern California, Los Angeles, California, 90033, United States|Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer, Los Angeles, California, 90048, United States|Hoag Memorial Hospital Presbyterian, Newport, California, 92663, United States|Sarah Cannon Research Institute - Denver DDU, Denver, Colorado, 80218, United States|Emory University - Winship Cancer Institute, Atlanta, Georgia, 30322, United States|New York Cancer & Blood Specialists, New York, New York, 11967, United States|University of Rochester - Wilmot Cancer Institute, Rochester, New York, 14642, United States|START San Antonio, San Antonio, Texas, 78229, United States

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

Primary Outcome Measures: Incidence of Adverse Events, Record all safety events during study including AEs, SAEs, DLTs, AESIs., Throughout study - anticipated 3.5 years
Secondary Outcome Measures: Measurement of maximum plasma concentration (Cmax) of QXL138AM, Measured from blood samples, Throughout study - anticipated 3.5 years|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), Part B of study - anticipated 1.5 years|Measurement of trough concentration (Ctrough) of QXL138AM, Measured from blood samples, Throughout study - anticipated 3.5 years|Measurement of area under the serum concentration-time curve (AUC) of QXL138AM, Measured from blood samples, Throughout study - anticipated 3.5 years|Incidence of Anti-drug Antibodies, Measured from blood samples, Throughout study - anticipated 3.5 years
Other Outcome Measures: 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, Throughout study - anticipated 3.5 years