Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT06760702
Brief 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.
Study:
NCT06760702
Study Brief:
Protocol Section:
NCT06760702