NCT06760702

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers

A Phase II, Open-label, Randomized, Dose-ranging Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers (TEJAS-2)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Aurigene Discovery Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicentre, randomized, Phase II study and will be conducted with co-primary objectives of the study are to assess the efficacy of AUR109, as measured by ORR and safety / tolerability at three different dose levels of the study drug in three cancer indications i.e., colorectal, ovarian cancer and renal cancer.

Detailed description

This is a Phase II, open-label, multicenter study evaluating the efficacy and safety of the drug AUR109 at three different dose levels (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, or renal cancer. Participants must have undergone at least two lines of systemic therapy and exhausted all local treatment options. The 200 mg and 300 mg doses will be administered continuously over a 21-day cycle, while the 400 mg dose will follow an interrupted regimen (2 weeks on, 1 week off). The drug is to be taken once daily according to the specified dosing schedule.

Conditions

• Ovarian Cancer
• Colorectal Cancer
• Renal Cancer

Interventions

Type	Name	Description
DRUG	AUR109 200mg	AUR109 200mg (once daily)
DRUG	AUR109 300mg	AUR109 300mg once daily
DRUG	AUR109 400mg	AUR109 400mg once daily

Timeline

• Start date: 2024-11-09
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-01-07
• Last updated: 2026-04-17

Locations

5 sites across 1 country: India

Regulatory

• FDA-regulated drug study