Solid TumorPhase 1NCT07086768
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing BSI-082 and Trastuzumab deruxtecan in people with Solid Tumor and Advanced Solid Tumor, run by Lei Zheng at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- BSI-082 and Trastuzumab deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to 7 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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
- 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.
Who cannot join
- 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.
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- 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.
- Has uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Has active primary immunodeficiency or active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and CD4 count. For the Dose-expansion phase only, participants with undetectable viral load or normalized CD4 count (CD4+ T-cell counts ≥ 350 cells/μL) and no opportunistic infection within the past 12 months will be eligible. These participants must be on established antiretroviral therapy for at least 4 weeks and have an HIV viral load <400 copies/mL prior to enrollment.
- Has active hepatitis B or C infection. Participants with past hepatitis C virus (HCV) infection and positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Participants with past or resolved hepatitis B virus infection are eligible only if confirmed by the Investigator.
- Has received a live, attenuated vaccine (messenger ribonucleic acid [mRNA] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s).
- Has any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results would make the patient inappropriate for entry into the trial.
- Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may interfere with the participant's participation in the clinical study or evaluation of the clinical study results.
- Women who are pregnant or lactating. All female patients of childbearing potential must have a negative serum pregnancy test prior to the first dose of study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Epp Goodwin, 210-450-5798, goodwin@uthscsa.edu
John Sarantopoulos, MD, 210-450-5946, sarantopoulo@uthscsa.edu
About this study
Official title: 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
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.
Read the detailed description
Phase 1a monotherapy dose-escalation part will establish the safety and tolerability of BSI-082 as single agent. Up to 30 patients with 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 will be enrolled. Recommended dose for expansion (RDE) will be determined in this phase and used in the phase 1b study.
Phase 1b combination dose-escalation and dose-expansion part will enroll up to 27 patients with Her2 positive locally advanced solid tumors that are indicated for the Standard of care T-DXd treatment.
- Conditions
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- BSI-082, Trastuzumab deruxtecan
- Keywords
- anti-SIRPα antibody, anti-signal regulatory protein alpha, Dose Escalation, Dose Expansion
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSI-082Drug
BSI-082 is a sterile solution for injection which contains the active ingredient at the nominal concentration of 50.0 mg/mL. T
Trastuzumab deruxtecanOther
Also called Standard of care treatment with
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: BSI-082 |
| Cohort b1: combined therapy | Experimental | Lower dose cohort of BSI-082 with established dose of T-DXd Receives: Drug: BSI-082; Other: Trastuzumab deruxtecan |
| Cohort b2: combined therapy | Experimental | Higher dose cohort of BSI-082 with established dose of T-DXd Receives: Drug: BSI-082; Other: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start26 Jan 2026
- Primary completion7 Aug 2027 (estimated)
- Study completion7 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Zheng
- Sponsor type
- University, hospital or other
- Collaborators
- Biosion, Inc.
- Responsible party
- Sponsor-investigator, Lei Zheng, The University of Texas Health Science Center at San Antonio
- Investigators
- Lei Zheng, MD, Study director, The University of Texas Health Science Center at San AntonioJohn Sarantopoulos, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086768
- Sponsor's protocol ID
- CTMS# 25-0042
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial subjects) must be prepared in conjunction with the Mays Cancer Center Data Safety Monitoring Board, the trial's statistician, and verification that all study data to be used for the publication has been monitored for accuracy by the Mays Quality Assurance (QA) team prior to publication or presentation.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07086768
- Acronym / sponsor ID
- CTMS# 25-0042
- Conditions
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- Keywords
- anti-SIRPα antibody, anti-signal regulatory protein alpha, Dose Escalation, Dose Expansion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Lei ZhengUniversity, hospital or other
- Collaborators
- Biosion, Inc.
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 7 Aug 2027 (estimated)
- Study completion
- 7 Aug 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1a monotherapy dose-escalation part will establish the safety and tolerability of BSI-082 as single agent. Up to 30 patients with 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 will be enrolled. Recommended dose for expansion (RDE) will be determined in this phase and used in the phase 1b study.
Phase 1b combination dose-escalation and dose-expansion part will enroll up to 27 patients with Her2 positive locally advanced solid tumors that are indicated for the Standard of care T-DXd treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: monotherapy | Experimental | Drug: BSI-082BSI-082 0.3mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle |
| Cohort 2: monotherapy | Experimental | Drug: BSI-082BSI-082 1mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle |
| Cohort 3: monotherapy | Experimental | Drug: BSI-082BSI-082 3mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle |
| Cohort 4: monotherapy | Experimental | Drug: BSI-082BSI-082 10mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle |
| Cohort 5: monotherapy | Experimental | Drug: BSI-082BSI-082 20mg/kg will be administrated as an IV infusion on Day 1 of each 21-day treatment cycle |
| Cohort b1: combined therapy | Experimental | Drug: BSI-082, Other: Trastuzumab deruxtecanLower dose cohort of BSI-082 with established dose of T-DXd |
| Cohort b2: combined therapy | Experimental | Drug: BSI-082, Other: Trastuzumab deruxtecanHigher dose cohort of BSI-082 with established dose of T-DXd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSI-082BSI-082 is a sterile solution for injection which contains the active ingredient at the nominal concentration of 50.0 mg/mL. T | Drug | Cohort 1: monotherapy, Cohort 2: monotherapy, Cohort 3: monotherapy, Cohort 4: monotherapy, Cohort 5: monotherapy, Cohort b1: combined therapy, Cohort b2: combined therapy |
| Trastuzumab deruxtecanAlso: Standard of care treatment withT-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. | Other | Cohort b1: combined therapy, Cohort b2: combined therapy |
Primary outcome
Number of Dose limiting toxicity Events
Time frame: Baseline 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial subjects) must be prepared in conjunction with the Mays Cancer Center Data Safety Monitoring Board, the trial's statistician, and verification that all study data to be used for the publication has been monitored for accuracy by the Mays Quality Assurance (QA) team prior to publication or presentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BSI-082 and Trastuzumab deruxtecan in people with Solid Tumor and Advanced Solid Tumor, run by Lei Zheng at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Sarantopoulos, MD (210 450 5946, sarantopoulo@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dose limiting toxicity Events (time frame: Baseline to 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.