A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma
Nammi Therapeutics Inc
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
Description
This is an open-label, multicenter, first in human (FIH) Phase 1a/1b study of QXL138AM in participants with locally advanced unresectable and/or metastatic solid tumors and multiple myeloma. This study will be conducted in two parts (A and B) and each part has two sub-parts for tumor type (1 and 2). Part A1 - Dose Escalation in Solid Tumors The following solid tumor types will initially be enrolled in this part: ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal, lung, prostate, and breast cancer. Dose escalation will use a standard 3+3 design, where 3 to 6 participants…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Participants with Multiple Myeloma * Have progressed despite standard…
Interventions
- BiologicalQXL138AM Injection every 2 weeks by IV Infusion
masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a
Locations (10)
- University of Southern CaliforniaLos Angeles, California
- Cedars-Sanai Medical Center - Samuel Oschin Comprehensive CancerLos Angeles, California
- Cedars-Sanai Medical CenterLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport, California
- Sarah Cannon Research Institute - Denver DDUDenver, Colorado
- Emory University - Winship Cancer InstituteAtlanta, Georgia