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Breast CancerPhase 1NCT07753226

A Study of SI-B036 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

A Phase 1 study testing SI-B036 in people with Breast Cancer and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic breast cancer and other… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer, Solid Tumor
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
39 participants
Where
1 siteChina
Study dates
18 Aug 2026to Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form and comply with the protocol requirements;
  • No gender restriction;
  • Age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Locally advanced or metastatic breast cancer and other solid tumors;
  • Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;
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  • Must have at least one measurable lesion as defined by RECIST v1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Toxicity from prior antitumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
  • No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
  • Organ function levels must meet the required criteria;
  • Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;
  • Urine protein ≤1+ or ≤1000 mg/24 h;
  • 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;
  • The trial participant must be able and willing to comply with the protocol-specified visits, treatment plan, laboratory tests, and other study-related procedures.

Who cannot join

  • Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose;
  • Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;
  • History of severe cardiac or cerebrovascular disease;
  • Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
  • Active autoimmune diseases and inflammatory diseases;
  • Prior experience of ≥ Grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;
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  • Diagnosis of another solid tumor within 5 years prior to the first dose;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
  • Poorly controlled hypertension;
  • Diabetes mellitus with poor glycemic control;
  • History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;
  • Concurrent pulmonary disease resulting in severe impairment of respiratory function;
  • Active central nervous system metastases;
  • History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;
  • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
  • Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;
  • 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;
  • Imaging findings suggesting tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;
  • Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;
  • History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;
  • Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
  • Pregnant or breastfeeding women;
  • Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Binghe Xu

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic breast cancer and other solid tumors.

Read the detailed description

The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).

Being tested
SI-B036
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SI-B036Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT07753226
Study groupRoleWhat they receive
SI-B036ExperimentalParticipants receive SI-B036 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: SI-B036

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Measured: Up to 21 days after the first dose

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

    Measured: Up to 21 days after the first dose

  3. Phase Ib: Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B036.

    Measured: Up to approximately 24 months

Secondary outcomes (12)

  1. Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of SI-B036. The type, frequency and severity of TEAE will be evaluated during the treatment of SI-B036.

    Measured: Up to approximately 24 months

  2. Cmax

    Cmax is defined as the maximum observed drug concentration in plasma after administration.

    Measured: Up to approximately 24 months

  3. Tmax

    Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.

    Measured: Up to approximately 24 months

  4. T1/2

    T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.

    Measured: Up to approximately 24 months

  5. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Measured: Up to approximately 24 months

  6. CL (Clearance)

    Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.

    Measured: Up to approximately 24 months

  7. Ctrough

    Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  8. Anti-drug Antibody (ADA)

    Frequency of anti-SI-B036 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

  9. Progression-free Survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Measured: Up to approximately 24 months

  10. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

    Measured: Up to approximately 24 months

  11. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  12. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start18 Aug 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753226
Sponsor's protocol ID
SI-B036-103
Status last verified
Sep 2026
First submitted
4 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SI-B036 in people with Breast Cancer and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

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 15 inclusion and 24 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 10 Sep 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 China. 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 Sa Xiao, PHD (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Dose limiting toxicity (DLT) (time frame: Up to 21 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07753226.

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 10 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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