Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLei Zheng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Read, understood, and provided written informed consent and must be willing to comply with all study requirements and procedures.
Adults ≥ 18 years of age at the time of informed consent form is signed.
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.
Patients having an FDA-approved indication for T-DXd (only for Phase 1b dose expansion).
Disqualifiers
Known allergies, hypersensitivity, or intolerance to monoclonal antibodies (mAbs) or formulation components of BSI-082.
Prior therapy with any SIRPα or CD47 targeting agents.
Has active autoimmune disease or a documented history of autoimmune disease, or history of potential autoimmune syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo, endocrinopathies, type 1 diabetes, or patients with resolved childhood asthma/atopy or other syndromes which would not be expected to recur in the absence of an external trigger (e.g., drug-related serum sickness or post-streptococcal glomerulonephritis). Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) and those who have not been hospitalized for asthma in the preceding 3 years will not be excluded from this study.
Toxicities of prior anticancer therapies have not resolved to ≤ Grade 1 or to baseline) prior to the first dose of study treatment (excluding alopecia, vitiligo, endocrinopathies on stable hormone replacement therapy, Grade 2 neuropathy from taxanes or platinum containing therapies and Grade 2 hearing loss from platinum-containing therapies).
Trial design
Design model
Sequential
Treatments tested in this trial
BSI-082
DrugBSI-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 interventionT-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.
Treatment groups
57 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Cohort 1: monotherapyExperimental treatment 1 intervention
Group B: Cohort 2: monotherapyExperimental treatment 1 intervention
Group C: Cohort 3: monotherapyExperimental treatment 1 intervention
Group D: Cohort 4: monotherapyExperimental treatment 1 intervention
Group E: Cohort 5: monotherapyExperimental treatment 1 intervention
Group F: Cohort b1: combined therapyExperimental treatment 2 interventions
Group G: Cohort b2: combined therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Dose limiting toxicity Events
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.
Time frame
Baseline to 42 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lei Zheng
Lead sponsor
The University of Texas Health Science Center at San Antonio
Sponsor institution
Biosin USA, Inc.
Collaborator
Source ClinicalTrials.gov