A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
NCT05607199 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2026-04-17
Summary
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).
Conditions
- Solid Tumor, Adult
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Non Hodgkin Lymphoma
Interventions
- DRUG
-
AUR103
Twice Daily
Sponsors & Collaborators
-
Aurigene Discovery Technologies Limited
lead INDUSTRY
Principal Investigators
-
Akhil Kumar, MD · Head Clinical Development
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-16
- Primary Completion
- 2024-11-27
- Completion
- 2024-11-27
- FDA Drug
- Yes
Countries
- India
Study Locations
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