NCT06755450

Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Aurigene Discovery Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Advanced Lymphomas

Interventions

Type	Name	Description
DRUG	AUR112	Once daily

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-01-15
• Completion: 2028-01-15
• First posted: 2025-01-01
• Last updated: 2026-01-13

Locations

19 sites across 1 country: India

Regulatory

• FDA-regulated drug study