Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
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
Timeline
- Start
- 2024-08-28
- Primary completion
- 2027-12-31
- Completion
- 2028-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QXL138AM | Protein / enzyme biologic | 0.001 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 0.003 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 0.01 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 0.03 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | QXL138AM | Protein / enzyme biologic | 4 mg/kg | Intravenous |