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Study of BSI-082 for Advanced or Metastatic Solid Tumors

This study is testing a new medication called BSI-082, both alone and in combination with Trastuzumab deruxtecan (T-DXd), for people with advanced or metastatic (spread) solid tumors. The study aims to find a safe and tolerable dose of BSI-082. You might be able to join if you are an adult (18 years or older) with a solid tumor that has not responded to previous treatments or has spread. For some parts of the study, your tumor will need to have a specific biomarker called HER2. The main goal is to track any dose-limiting toxicities (side effects that are severe enough to stop treatment) within the first 42 days.

Study design
This is an interventional study with two parts. The first part will test BSI-082 alone in up to 30 patients, gradually increasing the dose. The second part will test BSI-082 with T-DXd in up to 27 patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures events from baseline to 42 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07086768

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lei Zheng
~57 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:BSI-082Trastuzumab deruxtecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Dose limiting toxicity Events
Measured over Baseline to 42 days

Conditions

Solid Tumor
Advanced Solid Tumor
Metastatic Solid Tumor

Explore related trials

Solid Neoplasm

NCT07086768

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

John Sarantopoulos, MD
[email protected]
210 450 5946
Email the study team

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Eligibility criteria

Inclusion

Absolute Neutrophil Count (ANC) ≥ 1.5×109/L
Platelet counts ≥ 100×109/L
Hemoglobin ≥ 9 g/dL (without recent red blood cell transfusion within 2 weeks prior to study entry)
Creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula.
AST ≤ 2.5×Upper Limit Normal (ULN or patients with hepatic metastasis ≤ 5×ULN
ALT ≤ 2.5×ULN or patients with hepatic metastasis ≤ 5×ULN
Total Bilirubin ≤ 1.5×ULN, except for patients with Gilbert's syndrome from whom total bilirubin \< 3.0 × ULN or direct bilirubin \< 1.5 × ULN 11. Both male and female of childbearing potential patients enrolled in this trial as well as their partners must agree to use highly effective contraception during the study and for at least 10 months after discontinuing study treatment. Patients and/or partners who are surgically sterile or postmenopausal are exempt from this requirement.

What this trial measures

  • Number of Dose limiting toxicity EventsBaseline to 42 days

    Adverse events (AEs) as characterized by type, frequency, severity (as graded by national cancer institute common terminology criteria for adverse events, NCI CTCAE V5.0), timing, seriousness, and relationship to study treatment. •And Vital sign abnormalities and laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE V5.0) and timing.