Can a Dual-Pronged antibody outsmart advanced solid tumors?
NCT ID NCT07763639
First seen Aug 13, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This early-stage trial is testing an experimental drug called SI-B036, a bispecific antibody designed to target cancer cells in a unique way. The study involves adults with locally advanced or metastatic head and neck tumors or other solid tumors. The main goals are to assess the drug's safety, determine the right dose, and get an early look at whether it can help fight the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SI-B036, an experimental bispecific antibody given by intravenous infusion
- What this could lead to
- If successful, this could lead to a new treatment option for advanced head and neck and other solid tumors, potentially slowing or shrinking tumors.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not be effective or may cause significant side effects. The results will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements; 2. No gender restriction; 3. Age: ≥18 years and ≤75 years; 4. Life expectancy ≥3 months; 5. Locally advanced or metastatic head and neck tumors and other solid tumors; 6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 2 years; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. ECOG performance status score of 0 or 1; 9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 11. Organ function levels must meet the protocol requirements; 12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN); 13. Urine protein ≤2+ or ≤1000 mg/24h; 14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be lactating. All enrolled patients (regardless of gender) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment; 15. Participants must be capable of and willing to comply with the study visits, treatment plans, laboratory tests, and other study-related procedures as specified in the protocol. Exclusion Criteria: 1. Received chemotherapy, biotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose; 2. Received immunosuppressive medications within 2 weeks prior to the first dose; 3. History of severe cardiac or cerebrovascular disease; 4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 5. Active autoimmune diseases and inflammatory diseases; 6. History of ≥ Grade 3 toxicity related to anti-angiogenic therapy when previously receiving such treatment; 7. Diagnosis of another solid malignancy within 5 years prior to the first dose; 8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 9. Uncontrolled hypertension; 10. Diabetes mellitus with poor glycemic control; 11. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis; 12. Concurrent pulmonary disease resulting in severe impairment of respiratory function; 13. Active central nervous system (CNS) metastases; 14. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036; 15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection; 17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug; 18. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of study drug; 19. Imaging findings indicate that the tumor has invaded or encased the great thoracic vessels, pericardium, or heart; 20. Clinically significant hemorrhage or obvious bleeding tendency within 4 weeks prior to screening; 21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose; 22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose; 23. Pregnant or lactating women; 24. Any other conditions that, in the investigator's judgment, make the participant unsuitable for enrollment in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
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- Can a Two-Drug combo outsmart Treatment-Resistant breast cancer?
- Radioactive antibody aims to light up hidden solid tumors
- Experimental biological therapy VRT106 put to the test in advanced solid tumors