SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe SI-B036 is and how well people can handle its side effects. It is for people with solid tumors that have grown nearby or spread, after prior treatment, or when standard treatments do not work or are not available.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a solid tumor that cannot be cured with surgery or radiation. You must have had at least one standard treatment, or standard treatment does not work or is not available.
- Side effects from past cancer treatment must be mild or gone.
- Have no serious heart weakness. Your heart must pump out at least 50% of the blood in its main pumping chamber with each beat.
- Your organs must work well enough before you join.
- Part C, non-small cell lung cancer after immune checkpoint treatment: cancer must be confirmed by testing and cannot be removed by surgery or has spread. You must have had platinum chemotherapy, and standard treatments must no longer work or be suitable.
- Part C, non-small cell lung cancer without past immune checkpoint treatment: cancer must be confirmed by testing and cannot be removed by surgery or has spread. You must have had platinum chemotherapy. An FDA-approved test must show the PD-L1 protein on at least 1% of tumor cells.
- Part C, melanoma: have confirmed skin cancer that cannot be removed by surgery or has spread. It must have worsened after immune checkpoint treatment, which helps the immune system fight cancer.
- Part C, ovarian cancer: have confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer, which starts in the belly lining. It must have worsened or returned during or after chemotherapy. Past PARP inhibitor or bevacizumab treatment is allowed.
Who can't join
- Recent cancer treatment, major surgery, immune-boosting treatment, or immune-suppressing drugs may prevent joining. Waiting times depend on the treatment. Steroids used on the skin, inhaled, or injected locally are allowed. Another trial within 4 weeks or wounds that have not healed also prevent joining.
- Severe heart disease within 6 months; certain abnormal heart rhythms or medicines that cause them; or a blood clot, stroke, or mini-stroke within 6 months.
- Serious bleeding or bleeding risk; certain strong blood-thinning treatments; moderate or heavy coughing up blood; bleeding spots in the brain or spinal cord; or tumors growing into large blood vessels.
- Active diseases in which the immune system attacks the body, or active inflammatory diseases. Mild, stable cases on treatment need study doctor review. Serious lung disease or certain past, current, or suspected lung inflammation also prevents joining.
- Another cancer diagnosed within 5 years. Lung cancer is excluded from the dose-increase part only. Cancer starting in the brain or spinal cord, active or untreated spread there, or cancer in their lining is excluded. Treated brain spread may qualify if stable for 4 weeks, with no new or growing spots and no steroids for 14 days before screening.
- Past severe allergic reactions, an organ transplant, or a blood stem cell transplant from a donor.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- An abnormal passage between organs, a hole in the stomach or bowel, or a pocket of infection in the belly within 6 months. Other conditions the study doctor or sponsor considers unsuitable may also prevent joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. 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. Exclusion Criteria: * 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. * 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.
Study sites (7)
CT
- Yale Cancer Center · New Haven, CT 06510Thomas Ferencz · Study contact · 203-200-3100So Yeon Kim · Principal investigatorMore trials in New Haven
FL
- Florida Cancer Specialists Lake Nona · Orlando, FL 32827Stephanie Davis · Study contact · Stephanie.Davis@scri.comCesar Perez-Batista · Principal investigatorMore trials in Orlando
- Florida Cancer Specialists Sarasota · Sarasota, FL 34232Judy Wang · Principal investigatorMore trials in Sarasota
OK
- OU Health Stephenson Cancer Center · Oklahoma City, OK 73104Raid Aljumaily · Principal investigatorMore trials in Oklahoma City
TN
- Sarah Cannon Research Institute - Oncology Partners · Nashville, TN 37203Brittany Callaway · Study contact · Brittany.Callaway@scri.comMelissa Johnson · Principal investigatorMore trials in Nashville
TX
- Mary Crowley Cancer Research · Dallas, TX 75230Bianca Reyes · Study contact · bianca.reyes@scri.comDouglas Orr · Principal investigatorMore trials in Dallas
- MD Anderson · Houston, TX 77030Katharina Mikosh · Study contact · 713-563-6558 · kcmeyer@mdanderson.orgAung Naing · Principal investigatorMore trials in Houston