NCT06761586

A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)

A Phase 1, Open Label, Dose Escalation, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR104 in Patients With Select Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Aurigene Discovery Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104.In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AUR104 will be evaluated in dose escalation manner.

Detailed description

This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The dose escalation will be conducted in a rule-based manner in patients who do not have any available curative treatment options and have exhausted all effective therapies available locally. At a minimum, the patients must have relapsed or refractory disease to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin's disease. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104. In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AUR104 will be evaluated in dose escalation manner.

Conditions

• Select Relapsed/Refractory Lymphoid Malignancies

Interventions

Type	Name	Description
DRUG	AUR104	Once or twice a day

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2025-01-07
• Last updated: 2026-04-17

Locations

5 sites across 1 country: India

Regulatory

• FDA-regulated drug study