drugset / Trial / NCT05865002

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

NCT05865002 ↗

Phase 1 Recruiting 50 enrolled Aurigene Discovery Technologies Limited
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2023-09-05
Primary completion
2027-01
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject AUR107 Unknown 5 mg Oral
Subject AUR107 Unknown 10 mg Oral
Subject AUR107 Unknown 20 mg Oral
Subject AUR107 Unknown 40 mg Oral
Subject AUR107 Unknown 60 mg Oral
Subject AUR107 Unknown 90 mg Oral
Subject AUR107 Unknown 135 mg Oral
Subject AUR107 Unknown 200 mg Oral