NCT05861947

A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients With Select Relapsed Advanced Malignancies (JIVAN)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aurigene Discovery Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).

Detailed description

This is a Phase I, Open Label, Dose-Escalation, First in Human (FIH) study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR106 will be evaluated in patients with selected advanced solid tumors (Non-small cell lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer and Esophageal cancer), 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 safety, PK/PD and determine the Optimal Biological Dose (OBD) of AUR106, as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK and PD data.

Conditions

• Relapse
• Advanced Malignant Neoplasm
• Non Small Cell Lung Cancer
• Gastric Cancer
• Urothelial Carcinoma
• Kidney Cancer
• Colon Cancer
• Esophagus Cancer

Interventions

Type	Name	Description
DRUG	AUR106	Once or twice daily

Timeline

• Start date: 2023-08-26
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2023-05-17
• Last updated: 2026-04-17

Locations

6 sites across 1 country: India

Regulatory

• FDA-regulated drug study