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
Lei Zheng
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Read, understood, and provided written informed consent and must be willing to comply with all study requirements and procedures. 2. Adults ≥ 18 years of age at the time of informed consent form is signed. 3. Patients with histologically or cytologically confirmed 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. 4. Patients having an FDA-approved indication for T-DXd (only f…
Interventions
- DrugBSI-082
BSI-082 is a sterile solution for injection which contains the active ingredient at the nominal concentration of 50.0 mg/mL. T
- OtherTrastuzumab deruxtecan
T-DXd: Administrate as per the drug package insert and Investigator's guidance, and T-DXd can be continued after the patients been taken off from the study.
Location
- University of Texas Health Science Center at San AntonioSan Antonio, Texas