Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in Patients With Relapsed Advanced Malignancies( BHARAT-1)
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignancies (BHARAT-1).
This is a three-part (Part 1, Part 2A / 2B and Part 3A / 3B) Phase I, open-label, multi-center trial. In Part 1, the safety and tolerability of oral AUR103 Calcium will be evaluated among patients with advanced solid tumors who do not have any available curative or life prolonging treatment options and have exhausted all effective locally available therapies. In Part 2A, the safety and tolerability of oral AUR103 Calcium will be assessed in combination with Azacitidine in patients with AML / MDS. Thereafter, efficacy of the combination of AUR103 Calcium and Azacitidine will be assessed in AML / MDS in Part 2B. In Part 3A, the safety and tolerability of oral AUR103 Calcium will be assessed in combination with Rituximab in patients with NHL. Thereafter, efficacy of the combination of AUR103 Calcium and Rituximab will be assessed in NHL in Part 3B. ;
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