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Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors

NCT07086768 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

  • Solid Tumor
  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Interventions

DRUG

BSI-082

BSI-082 is a sterile solution for injection which contains the active ingredient at the nominal concentration of 50.0 mg/mL. T

OTHER

Trastuzumab 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.

Sponsors & Collaborators

  • Biosin USA, Inc.

    collaborator UNKNOWN

  • Lei Zheng

    lead OTHER

Principal Investigators

  • Lei Zheng, MD · The University of Texas Health Science Center at San Antonio

  • John Sarantopoulos, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-08-07
Completion
2028-08-07
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086768 on ClinicalTrials.gov