NCT05984147

A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-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

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Detailed description

This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will be evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who do not have any available curative or life-prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR108 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.

Conditions

• Relapsed Advanced Lymphomas

Interventions

Type	Name	Description
DRUG	AUR108	3 Days dosing, and 4 days no dose in a week

Timeline

• Start date: 2023-10-19
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2023-08-09
• Last updated: 2026-04-17

Locations

27 sites across 1 country: India

Regulatory

• FDA-regulated drug study