Locally Advanced /Metastatic Solid TumorsPhase 1NCT07857616
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
A Phase 1 study testing SI-B036 in people with Locally Advanced /Metastatic Solid Tumors and Locally Advanced / Metastatic Solid Tumors, run by SystImmune Inc. at 7 sites in United States.
Trial summary
The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors, Metastatic Solid Cancers
- What is being tested?
- SI-B036
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2026to Oct 2029
- 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
- Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available.
- Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
- Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%.
- Has adequate organ function before enrollment
- PART C Additional Inclusion Criteria (Dose Expansion Only)
- For immuno-oncology (IO)-exposed non-small cell lung cancer (NSCLC): histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in subjects who are previously exposed to immune checkpoint inhibitor (ICI) therapy (IO-exposed) and whose disease is refractory to standard of care (SOC) therapy or for whom no appropriate standard treatment options are available. In addition, subjects must have received at least one prior line of platinum therapy.
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- For IO naïve NSCLC: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC in subjects who are not previously exposed to ICI therapy. Subjects must also have PD-L1 expression ≥1% (tumor proportion score [TPS]) as determined by an FDA-approved assay. In addition, subjects must have received at least one prior line of platinum therapy.
- For Melanoma: histologically confirmed unresectable or metastatic melanoma with prior treatment with an immune checkpoint inhibitor regimen and documented disease progression following such therapy.
- For Ovarian Cancer: has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous chemotherapy with or without a poly (ADP-ribose) polymerase (PARP) inhibitor. Prior bevacizumab treatment is allowed.
Who cannot join
- Chemotherapy, biological therapy, immunotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral drugs such as Ticio such as capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.
- Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer).
- Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted.
- Participants with history of severe heart disease within 6 months before enrollment.
- Participants with prolonged QT interval (QTcF >470 msec), complete left bundle branch block, Grade 3 atrioventricular block, or a history of additional risk factors for Torsades de Pointes (TdP) or any current concomitant medication known to prolong the QT/QTc interval or cause TdP.
- Other malignant tumors were diagnosed within 5 years prior to the first administration.
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- For the dose escalation portion of the study only, participants with a primary diagnosis of lung cancer are excluded.
- Participants with a thromboembolic event (eg, deep vein thrombosis [DVT] or pulmonary embolism [PE]), stroke, or transient ischemic attack (TIA) within 6 months before screening.
- Participants with active or recent clinically significant bleeding are excluded, or who are at risk of bleeding due to clinically significant platelet abnormalities or coagulopathy, or who require full-dose anticoagulation or high-intensity antiplatelet therapy on high dose nonsteroidal anti-inflammatory drugs (NSAIDs).
- Active autoimmune diseases and inflammatory diseases. For autoimmune conditions that are active but stable and low-grade on systemic therapy, discussion with the medical monitor is required prior to screening.
- Participants with advanced/clinically significant lung diseases, who have a history of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening, or concurrent pulmonary disease resulting in severe impaired respiratory function.
- Participants with primary tumors in the central nervous system (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to Screening.
- Participant with active or untreated hemorrhagic CNS lesions.
- Participants with a history of anaphylaxis or severe hypersensitivity reactions.
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Subjects with recent surgery, biopsy, or invasive procedures without adequate wound healing prior to study enrollment.
- Participated in another clinical trial within 4 weeks prior to first dose of study treatment.
- Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose.
- Participant with moderate or major hemoptysis history.
- Participant has tumors invading large blood vessels
- Other conditions that the Investigator or sponsor believes are not suitable for participating in this clinical trial.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
Bianca Reyes, bianca.reyes@scri.com
Douglas Orr
MD Anderson
Houston, Texas, 77030
Katharina Mikosh, 713-563-6558, kcmeyer@mdanderson.org
Aung Naing
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee, 37203
Brittany Callaway, Brittany.Callaway@scri.com
Melissa Johnson
Yale Cancer Center
New Haven, Connecticut, 06510
Thomas Ferencz, 203-200-3100
So Yeon Kim
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Raid Aljumaily
Florida Cancer Specialists Lake Nona
Orlando, Florida, 32827
Stephanie Davis, Stephanie.Davis@scri.com
Cesar Perez-Batista
Florida Cancer Specialists Sarasota
Sarasota, Florida, 34232
Judy Wang
About this study
Official title: SI-B036-ST-101: A Multicenter, Open-Label, Phase 1/1b, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SI-B036 in Adult Patients With Advanced/Metastatic Solid Tumors That Are Refractory to Standard Therapies
The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.
Read the detailed description
This study is an open-label, multicenter, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary efficacy of SI-B036 in participants with locally advanced or metastatic solid tumors.
- Conditions
- Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors, Metastatic Solid Cancers, Non Small Cell Lung Cancer, Lung Cancer, Melanoma
- Being tested
- SI-B036
- Keywords
- PD-L1, VEGFR-2, First in Human, FIH
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-B036Drug
SI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental SI-B036 administered Day 1 per cycle | Experimental | SI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks Receives: Drug: SI-B036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Dose-Limiting Toxicities
A DLT is defined as any of the following:
- Grade 4 neutrophil count decreased lasting >7 days.
- Grade ≥3 febrile neutropenia of any duration.
- Grade ≥3 platelet count decreased with clinically significant hemorrhage.
- Grade 4 thrombocytopenia lasting >72 hours
- Death not related to disease progression or extraneous cause.
- Hy's law cases
- Grade ≥3 infusion-related reactions (IRRs) leading to permanent discontinuation
- Grade ≥3 non-hematologic toxicities, except for:
- Grade 3 nausea/vomiting or diarrhea for <72 hours with adequate antiemetic and other supportive care;
- Grade 3 fatigue for less than 1 week;
- Grade ≥3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical interventions;
- Grade ≥3 amylase or lipase that is not associated with symptoms or clinical manifestations of pancreatitis and does not require hospitalization
Measured: 24 months
Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)
Measuring the number of patients with serious adverse events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)
Measured: 24 months
Participants with abnormal physical examination findings
Measure the number of participants with abnormal physical examination findings.
Measured: 24 months
Participants with abnormal lab results
Measure the number of participants with abnormal clinical laboratory values
Measured: 24 months
Participants with abnormal ECG reading
Patients with abnormal ECG parameters (including the change from-baseline ECG parameters: heart rate [HR]; PR; QTcF; and QRS intervals [∆HR, ∆PR, ∆QTcF, and ∆QRS])
Measured: 24 months
To determine the maximum tolerated dose (MTD) if reached or minimum safe and pharmacologically effective dose (MSED).
The actual number of subjects enrolled and dose levels to be explored in this study will depend on the MTD and/or MSED based on DLTs reported during the DLT observation period.
Measured: 24 months
Secondary outcomes (14)
Cmax of SI-B036
Calculate maximum (peak) observed concentration of SI-B036
Measured: 24 months
Cmax of anti-drug antibodies (ADAs) to SI-B036
Calculate maximum (peak) observed concentration of anti-SI-B036 antibodies
Measured: 24 months
Tmax of SI-B036
Calculate time of maximum observed concentration of SI-B036
Measured: 24 months
Tmax of anti-SI-B036 antibodies
Calculate time of maximum observed concentration of anti-SI-B036 antibodies
Measured: 24 months
AUC(0-8) of SI-B036
Calculate area under the serum concentration-time curve of SI-B036 from time 0 to 8 hours
Measured: 24 months
AUC(0-8) of anti-SI-B036 antibodies
Calculate area under the serum concentration-time curve of anti-SI-B036 antibodies from time 0 to 8 hours
Measured: 24 months
AUC(last) of SI-B036
Calculate area under the serum concentration-time curve up of SI-B036 to the last quantifiable time (0 to 8 hours)
Measured: 24 months
AUC(last) of anti-SI-B036 antibodies
Calculate area under the serum concentration-time curve up of anti-SI-B036 antibodies to the last quantifiable time (0 to 8 hours)
Measured: 24 months
Overall Response Rate (ORR)
To assess the clinical efficacy of SI-B036 as measured by ORR using RECIST criteria v1.1
Measured: 24 months
Disease Control Rate (DCR)
To assess the clinical efficacy of SI-B036 as measured by DCR using RECIST criteria v 1.1
Measured: 24 months
Time To Response (TTR)
To assess the clinical efficacy of SI-B036 as measured by TTR using RECIST criteria v 1.1
Measured: 24 months
Progression-Free Survival (PFS)
To assess the clinical efficacy of SI-B036 as measured by PFS using RECIST criteria v 1.1
Measured: 24 months
Overall Survival (OS)
To assess the clinical efficacy of SI-B036 as measured by OS using RECIST criteria v 1.1
Measured: 24 months
Duration of response (DoR)
To assess the clinical efficacy of SI-B036 as measured by DoR using RECIST criteria v 1.1
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced /Metastatic Solid TumorsStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SystImmune Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857616
- Sponsor's protocol ID
- SI-B036-ST-101
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SI-B036-ST-101: A Multicenter, Open-Label, Phase 1/1b, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SI-B036 in Adult Patients With Advanced/Metastatic Solid Tumors That Are Refractory to Standard Therapies
- ClinicalTrials.gov ID
- NCT07857616
- Acronym / sponsor ID
- SI-B036-ST-101
- Conditions
- Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors, Metastatic Solid Cancers, Non Small Cell Lung Cancer, Lung Cancer, Melanoma
- Keywords
- PD-L1, VEGFR-2, First in Human, FIH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- SystImmune Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 5 Oct 2026 (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.
The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.
Detailed description
This study is an open-label, multicenter, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary efficacy of SI-B036 in participants with locally advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental SI-B036 administered Day 1 per cycle | Experimental | Drug: SI-B036SI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available.
- Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
- Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%.
- Has adequate organ function before enrollment
- PART C Additional Inclusion Criteria (Dose Expansion Only)
Key exclusion criteria (22 listed)
- Chemotherapy, biological therapy, immunotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral drugs such as Ticio such as capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.
- Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer).
- Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted.
- Participants with history of severe heart disease within 6 months before enrollment.
- Participants with prolonged QT interval (QTcF >470 msec), complete left bundle branch block, Grade 3 atrioventricular block, or a history of additional risk factors for Torsades de Pointes (TdP) or any current concomitant medication known to prolong the QT/QTc interval or cause TdP.
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 |
|---|---|---|
| SI-B036SI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks | Drug | Experimental SI-B036 administered Day 1 per cycle |
Primary outcome
Participants with Dose-Limiting Toxicities
Time frame: 24 months
A DLT is defined as any of the following: * Grade 4 neutrophil count decreased lasting >7 days. * Grade ≥3 febrile neutropenia of any duration. * Grade ≥3 platelet count decreased with clinically significant hemorrhage. * Grade 4 thrombocytopenia lasting >72 hours * Death not related to disease progression or extraneous cause. * Hy's law cases * Grade ≥3 infusion-related reactions (IRRs) leading to permanent discontinuation * Grade ≥3 non-hematologic toxicities, except for: * Grade 3 nausea/vomiting or diarrhea for <72 hours with adequate antiemetic and other supportive care; * Grade 3 fatigue for less than 1 week; * Grade ≥3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical interventions; * Grade ≥3 amylase or lipase that is not associated with symptoms or clinical manifestations of pancreatitis and does not require hospitalization
Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)
Time frame: 24 months
Measuring the number of patients with serious adverse events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)
Participants with abnormal physical examination findings
Time frame: 24 months
Measure the number of participants with abnormal physical examination findings.
Participants with abnormal lab results
Time frame: 24 months
Measure the number of participants with abnormal clinical laboratory values
Participants with abnormal ECG reading
Time frame: 24 months
Patients with abnormal ECG parameters (including the change from-baseline ECG parameters: heart rate [HR]; PR; QTcF; and QRS intervals [∆HR, ∆PR, ∆QTcF, and ∆QRS])
To determine the maximum tolerated dose (MTD) if reached or minimum safe and pharmacologically effective dose (MSED).
Time frame: 24 months
The actual number of subjects enrolled and dose levels to be explored in this study will depend on the MTD and/or MSED based on DLTs reported during the DLT observation period.
14 secondary outcomes
Cmax of SI-B036
Time frame: 24 months
Cmax of anti-drug antibodies (ADAs) to SI-B036
Time frame: 24 months
Tmax of SI-B036
Time frame: 24 months
Tmax of anti-SI-B036 antibodies
Time frame: 24 months
AUC(0-8) of SI-B036
Time frame: 24 months
AUC(0-8) of anti-SI-B036 antibodies
Time frame: 24 months
AUC(last) of SI-B036
Time frame: 24 months
AUC(last) of anti-SI-B036 antibodies
Time frame: 24 months
Overall Response Rate (ORR)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Time To Response (TTR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Duration of response (DoR)
Time frame: 24 months
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SI-B036 in people with Locally Advanced /Metastatic Solid Tumors and Locally Advanced / Metastatic Solid Tumors, run by SystImmune Inc. at 7 sites 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 9 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: opening soon, as of the sponsor's last update on 5 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 7 sites 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 Stephanie Yee (425-453-6841, stephanie.yee@systimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Dose-Limiting Toxicities (time frame: 24 months). The study lists 6 primary outcomes in all. 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 5 Oct 2026.