Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT06755450
Brief Summary:
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
Detailed Description:
The main objective of Part 1 will be to evaluate the safety and tolerability of the study drug AUR112.
Dose escalation of single agent AUR112 will be conducted in the classic 3+3 design. Safety including Dose Limiting Toxicities (DLTs), PK, and PD will be assessed at each dose. Dose escalation will continue until safety limits are reached or the escalation will stop earlier if PK/PD data suggest that a biologically active dose has reached.
The objective is to determine dose(s) which will be investigated in future trials.
Study:
NCT06755450
Study Brief:
Protocol Section:
NCT06755450