Multiple Myeloma Clinical Trial
Official title:
Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hematological Malignancies
This is a multicenter, open-label, dose escalation Phase 1 study.
This is a multicenter, open-label, dose escalation, Phase 1/1b study.
For Parts 1, 2, and 3 of the study, the primary objective is to determine the highest dose
of TG02 citrate that can safely be given to patients with different types of hematological
malignancy.
For Part 4, the primary objective is to evaluate the safety and tolerability of once-weekly
dosing at the maximum-tolerated dose/ Recommended Phase 2 Dose of TG02 in combination with
carfilzomib.
This study consists of four parts:
- Part 1: single agent TG02 in acute leukemia patients
- Part 2: single agent TG02 in multiple myeloma patients
- Part 3: TG02 in combination with carfilzomib in multiple myeloma patients
- Part 4: TG02 in combination with carfilzomib in carfilzomib refractory multiple myeloma
patients.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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