NCT05865002

A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Aurigene Discovery Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 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 malignancies. The safety and tolerability of oral AUR107 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 the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR107 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.

Conditions

• Relapsed Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	AUR107	Once daily

Timeline

• Start date: 2023-09-05
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2023-05-18
• Last updated: 2026-04-17

Locations

37 sites across 1 country: India

Regulatory

• FDA-regulated drug study