Phase 1: testing BSI-082 for Solid Tumor
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.
Official registry: https://clinicaltrials.gov/study/NCT07086768 · Lei Zheng · enrollment listed as 57
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are BSI-082, or Trastuzumab deruxtecan. The registry lists allocation as randomized. This is a study that will enroll patients with cancer who have tumors that may have spread.
They plan to enroll about 57 people at San Antonio. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: BSI-082, Trastuzumab deruxtecan
Primary outcome (registry wording): Number of Dose limiting toxicity Events
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Patients having an FDA-approved indication for T-DXd (only for Phase 1b dose expansion)
- With 4 weeks or 5 half-lives (whichever is shorter) of prior anticancer therapies (only for Phase 1a dose escalation)
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per RECISIT V1.1
- Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment
- Main organ functions meet the following criteria:
Who the registry excludes
- 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 other malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 5 years
- Occurrence of immune related toxicity necessitating permanent discontinuation or immune related toxicity that required treatment with a TNF inhibitor (e.g., infliximab) in patients with previous immunotherapy
- Medical history of myocardial (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class II to IV)
- Any of the following within 6 months of enrollment: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic events, or pulmonary embolism
- Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \>470 ms based on average of the screening triplicate 12-lead electrocardiogram (ECG)
Public study contact (from the registry)
John Sarantopoulos, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- University of Texas Health Science Center at San Antonio — San Antonio, Texas (recruiting)
FAQ about this NCT record
Is NCT07086768 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07086768?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07086768?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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