RecruitingPhase 2NCT06760702

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)

Sponsor

Aurigene Discovery Technologies Limited

Enrollment

90 participants

Start Date

Nov 9, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AUR109 in patients with advanced colorectal cancer, ovarian cancer (including fallopian tube and peritoneal cancer), or kidney cancer who have already tried multiple treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with one of these cancers: colorectal adenocarcinoma, epithelial ovarian cancer, or kidney (renal cell) cancer - You have received at least two prior lines of treatment including standard therapies for your cancer type - You have exhausted other available treatment options **You may NOT be eligible if...** - You have not tried standard first-line treatments for your cancer type - Your overall health is too poor to participate - You have other conditions that make trial participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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