Can a Dual-Pronged antibody outsmart advanced cancers?
NCT ID NCT07753226
First seen Aug 07, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This early-stage trial is testing an investigational drug called SI-B036, a bispecific antibody designed to target cancer cells in people with locally advanced or metastatic breast cancer and other solid tumors. The study aims to find the safest dose and understand how the drug behaves in the body, while also looking for early signs that it can shrink tumors. Participants receive the drug by intravenous infusion over a three-week cycle, and the trial will closely monitor side effects and any antitumor activity.
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, a bispecific antibody given by intravenous infusion
- What this could lead to
- If successful, this could lead to a new treatment option for advanced breast cancer and other solid tumors, potentially slowing disease progression.
- 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 not be known until the study is complete.
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 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- 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 comply with the protocol requirements; 2. No gender restriction; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Locally advanced or metastatic breast cancer and other solid tumors; 6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. Toxicity from prior antitumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the required criteria; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal; 13. Urine protein ≤1+ or ≤1000 mg/24 h; 14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must be non-lactating; all enrolled patients (both males and females) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion; 15. The trial participant must be able and willing to comply with the protocol-specified visits, treatment plan, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose; 2. Receipt of immunosuppressive drug therapy 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. Prior experience of ≥ Grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment; 7. Diagnosis of another solid tumor within 5 years prior to the first dose; 8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 9. Poorly controlled hypertension; 10. Diabetes mellitus with poor glycemic control; 11. History of interstitial lung disease (ILD) requiring steroid 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 metastases; 14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036; 15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug; 18. Presence of pleural, abdominal, or pelvic effusion, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of the study drug; 19. Imaging findings suggesting tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart; 20. Trial participants with clinically significant bleeding 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 breastfeeding women; 24. Other conditions deemed by the investigator to make the participant unsuitable for participation 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
1 site. 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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Cancer Hospital Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, China
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