Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-29 @ 8:39 PM
Study NCT ID:
NCT07086768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Lei Zheng
Organization:
Study Overview
Official Title:
A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: