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

NCT07086768 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CTMS# 25-0042
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

anti-SIRPα antibody; anti-signal regulatory protein alpha; Dose Escalation; Dose Expansion

Outcome Measures

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.

  Baseline to 42 days

Study Arms (7)

Cohort 1: monotherapy

EXPERIMENTAL

BSI-082 0.3mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle

Drug: BSI-082

Cohort 2: monotherapy

EXPERIMENTAL

BSI-082 1mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle

Drug: BSI-082

Cohort 3: monotherapy

EXPERIMENTAL

BSI-082 3mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle

Drug: BSI-082

Cohort 4: monotherapy

EXPERIMENTAL

BSI-082 10mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle

Drug: BSI-082

Cohort 5: monotherapy

EXPERIMENTAL

BSI-082 20mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle

Drug: BSI-082

Cohort b1: combined therapy

EXPERIMENTAL

Lower dose cohort of BSI-082 with established dose of T-DXd

Drug: BSI-082; Other: Trastuzumab deruxtecan

Cohort b2: combined therapy

EXPERIMENTAL

Higher dose cohort of BSI-082 with established dose of T-DXd

Drug: BSI-082; Other: Trastuzumab deruxtecan

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

Cohort 1: monotherapy; Cohort 2: monotherapy; Cohort 3: monotherapy; Cohort 4: monotherapy; Cohort 5: monotherapy; Cohort b1: combined therapy; Cohort b2: combined therapy

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.

Also known as: Standard of care treatment with

Cohort b1: combined therapy; Cohort b2: combined therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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:
• 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

You may not qualify if:

• 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).
• 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).
• Uncontrolled hypertension (resting systolic blood pressure\>180 mmHg or diastolic blood pressure\>110 mmHg) and/or severe arrhythmia within 28 days before enrollment.
• Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
• Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder.
• Any autoimmune, connective tissue or inflammatory disorders where there is documented or suspicion of pulmonary involvement at the time of screening.
• Prior complete pneumonectomy.
• Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.

Sponsors & Collaborators

• Lei Zheng: lead
• Biosin USA, Inc.: collaborator

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Zheng, MD

  The University of Texas Health Science Center at San Antonio

  STUDY DIRECTOR

• John Sarantopoulos, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Sarantopoulos, MD

CONTACT

210 450 5946; sarantopoulo@uthscsa.edu

Epp Goodwin

CONTACT

210 450 5798; GOODWINE@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director of University of Texas Health Science Center at San Antonio Cancer Center

Model Details: This is a phase Ia/Ib, open-label, dose-escalation and dose-expansion study designed to evaluate BSI-082 monotherapy and combined therapy with Trastuzumab deruxtecan (T-DXd) in patients with locally advanced or metastatic solid tumors. A Phase 1a/1b, open-label, dose-escalation and dose expansion study. This study will have 2 parts: Phase Ia monotherapy dose-escalation and Phase Ib combination and dose-expansion.A traditional 3+3 method will be applied for dose escalation phase for Phase 1a. Phase 1b will have 2 dose cohorts, a lower dose and a higher dose cohort.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 7, 2027
• Study Completion (Estimated): August 7, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion and data analysis for publication.