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:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT07086768
Brief Summary:
This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given.
There will be 2 parts to the study. For the first part of the study only one medication will be taken, and the dose changed to a higher dose over time.
In the second part of the study tow medications will be taken and the dose of the medication may be changed to a higher dose.
Detailed Description:
Phase 1a monotherapy dose-escalation part will establish the safety and tolerability of BSI-082 as single agent. Up to 30 patients with locally advanced or metastatic solid tumors who have relapsed, or been non-responsive, or have developed disease progression through standard systemic therapy, or have been ineligible for standard systemic therapy known to confer clinical benefit will be enrolled. Recommended dose for expansion (RDE) will be determined in this phase and used in the phase 1b study.
Phase 1b combination dose-escalation and dose-expansion part will enroll up to 27 patients with Her2 positive locally advanced solid tumors that are indicated for the Standard of care T-DXd treatment.
Study:
NCT07086768
Study Brief:
Protocol Section:
NCT07086768