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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Lei Zheng
Study ID
NCT07086768
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 26, 2026
Status verified
Jul 2025
Primary completion
Aug 7, 2027
Completion
Aug 7, 2028

Study Design

Enrollment
57 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: monotherapy
    BSI-082 0.3mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle
  • Experimental: Cohort 2: monotherapy
    BSI-082 1mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle
  • Experimental: Cohort 3: monotherapy
    BSI-082 3mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle
  • Experimental: Cohort 4: monotherapy
    BSI-082 10mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle
  • Experimental: Cohort 5: monotherapy
    BSI-082 20mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle
  • Experimental: Cohort b1: combined therapy
    Lower dose cohort of BSI-082 with established dose of T-DXd
  • Experimental: Cohort b2: combined therapy
    Higher dose cohort of BSI-082 with established dose of T-DXd

Primary Outcome Measure

Number of Dose limiting toxicity Events [ Time Frame: Baseline to 42 days ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of Texas Health Science Center at San AntonioSan AntonioTexas78229

Find similar trials in San Antonio, TX

By research site
University of Texas Health Science Center at San Antonio· San Antonio, TX

Related Studies