NCT05605119

First in Human, Dose Escalation, Dose Expansion Study of AUR105

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR105 in Patients With Relapsed Advanced Malignancies (SURYA-1)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Aurigene Discovery Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, First in Human, Phase 1 study of AUR 105 in adult patients with advanced malignancies. The study will have two parts: a Dose Escalation Part and Dose Expansion Part.

Detailed description

This is a Phase I, Open label First in Human Study in adult patients with relapsed advanced malignancies. The study will have two parts. Dose escalation part and Dose expansion part

Conditions

• Solid Tumor, Adult
• Non-hodgkin Lymphoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	AUR105	Once daily

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-11-04
• Last updated: 2026-04-17

Locations

9 sites across 1 country: India

Regulatory

• FDA-regulated drug study