First-in-Human Phase 1a1b Study of QXL138AM for Safety and Tolerability in Adults With Advanced or Metastatic Solid Tumors and Multiple Myeloma

What this Trial Is About

Researchers are evaluating QXL138AM in adults with locally advanced unresectable andor metastatic solid tumors and multiple myeloma in this Phase 1a1b study. It is an open-label, multicenter first-in-human trial designed to assess the safety, how the drug moves through the body, and early signs of activity. The study includes patients who have progressed despite standard therapies or have no effective treatment options available. The study is divided into two main parts, each with two sub-parts based on tumor type. Part A involves dose escalation Part A1 enrolls patients with various solid tumors including ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal, lung, prostate, and breast cancers using a modified 33 design to find the recommended dose. Part A2 focuses on multiple myeloma dose escalation once the solid tumor dose is identified or signs of activity appear. Part B involves dose expansion to further explore safety and anti-tumor activity in selected solid tumors Part B1 and multiple myeloma Part B2, with patients randomized to receive the recommended dose or one dose level lower. Participants will receive QXL138AM by intravenous infusion every two weeks, administered over 30 to 60 minutes. Researchers will monitor safety through adverse events over approximately 3.5 years, measure drug levels in the blood, assess the presence of anti-drug antibodies, and evaluate anti-tumor activity during dose expansion. The study includes various assessments such as tumor measurements and blood tests to track response and tolerability throughout the treatment and follow-up periods.

Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma