Locally Advanced or Metastatic Epithelial TumorPhase 1NCT04603287
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors
A Phase 1 study testing SI-B001 in people with Locally Advanced or Metastatic Epithelial Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Epithelial Tumor
- What is being tested?
- SI-B001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 17 Apr 2020to Dec 2025
- 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
- Participants must sign the informed consent form voluntarily and follow the plan requirements.
- No gender limit.
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).
- Expected survival time ≥ 3 months.
- Locally advanced or metastatic epithelial malignancies are confirmed by histopathology and/or cytology that are incurable or currently without standard treatment.
- Participants must agree to provide archived tumor tissue specimens or fresh tissue samples within 6 months of the primary tumor or metastasis; in phase Ia, if the participant is unable to provide tumor tissue samples, the investigator will evaluate whether the participant could be enrolled if other criteria are fit to join the group.
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- Participants must have at least one measurable lesion that meets the definition of RECIST v1.1.
- Physical fitness score ECOG 0 or 1 point.
- The toxicity of previous anti-tumor treatments has been restored to NCI-CTCAE v5.0 definition ≤ 1 (except for hair loss).
- No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%, (hypersensitivity) troponin T<ULN.
- The organ function must meet the following requirements and standards: a) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L; B) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN for participants without liver metastasis, AST and ALT ≤5.0 ULN for liver metastases; c) Kidney function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to the Cockcroft and Gault formula).
- Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT)≤1.5ULN.
- Urine protein≤2%2B (measured with test paper) or≤1000mg/24h (urine).
- For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating; all participants (regardless of male or female) in the group should be treated throughout the treatment. Adequate barrier contraceptive measures should be taken during the treatment and 6 months after the treatment.
Who cannot join
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2weeks prior to the first administration.
- If there is a history of vaccination within 3 months prior to the first administration, it is allowed to receive inactivated influenza vaccine within 30 days prior to the first administration, and the treatment of live attenuated vaccine is not allowed.
- Participants with history of severe heart disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc.
- Participants with prolonged QT interval (male QTc> 450 msec or female QTc> 470 msec), complete left bundle branch block, III grade atrioventricular block.
- Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type I diabetes, hypothyroidism that can be controlled only by alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).
- Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection.
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- Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg).
- Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, including participants with resting dyspnea, or requiring continuous oxygen therapy, or a history of interstitial lung disease (ILD).
- Symptoms of active central nervous system metastasis. However, participants with stable brain metastasis or stable epidural spinal cord compression history can be included. Stable is defined as: a. With or without antiepileptic drugs, the seizure-free state lasts for more than 12 weeks; b. There is no need to use glucocorticoids; c. Continuous multiple MRI (scanning interval at least 8 weeks) showed a stable state in imaging.
- Participants who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of SI-B001.
- Participants have a history of autologous or allogeneic stem cell transplantation.
- In the adjuvant (or neoadjuvant) treatment of anthracyclines, the cumulative dose of anthracyclines is> 360 mg/m2.
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number> 104) or hepatitis C virus (HCV) infection.
- Participants with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- Other conditions that the investigator believes that it is not suitable for participating in this clinical trial.
- Participated in another clinical trial within 4 weeks prior to participating in the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
West China Hospital，Sichuan University
Chengdu, Sichuan
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510006
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors
In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001.
In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.
In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of SI-B001 in patients with locally advanced or metastatic epithelial tumors will be evaluated.
- Being tested
- SI-B001
- Keywords
- Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Esophageal cancer, Colorectal cancer
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Esophageal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-B001Drug
Administration by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Study treatment | Experimental | Participants receive SI-B001 as intravenous infusion for the first cycle (4 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-B001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Dose limiting toxicity (DLT)
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle (28 days) 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 28 days after the first dose of SI-B001
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 (within 28 days of the first administration).
Measured: Up to 28 days after the first dose of SI-B001
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-B001.
Measured: Up to 28 days after the first dose of SI-B001
Secondary outcomes (14)
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-B001. The type, frequency and severity of TEAE will be evaluated during the treatment of SI-B001.
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of SI-B001 will be investigated.
Measured: Up to 28 days after the first dose of SI-B001
Tmax
Time to maximum serum concentration (Tmax) of SI-B001 will be investigated.
Measured: Up to 28 days after the first dose of SI-B001
T1/2
Half-life (T1/2) of SI-B001 will be investigated.
Measured: Up to 28 days after the first dose of SI-B001
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 28 days after the first dose of SI-B001
CL (Clearance)
CL in the serum of SI-B001 per unit of time will be investigated.
Measured: Up to 28 days after the first dose of SI-B001
Ctrough
Ctough is defined as the lowest serum concentration of SI-B001 prior to the next dose will be administered.
Measured: Up to 28 days after the first dose of SI-B001
ADA (anti-drug antibody)
Incidence and titer of ADA of SI-B001 will be evaluated.
Measured: Up to approximately 24 months
Nab (neutralizing antibody)
Incidence and titer of Nab of SI-B001 will be evaluated.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: Up to approximately 24 months
Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Progression-free Survival (PFS)
The PFS is defined as the time from the participant's first dose of SI-B001 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Overall survival
The OS is defined as the time from the participant's first dose of SI-B001 to the time of death from any cause
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.
- First posted26 Oct 2020
- Study start17 Apr 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Epithelial TumorStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603287
- Sponsor's protocol ID
- SI-B001/CC-E/H3101
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2020
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT04603287
- Acronym / sponsor ID
- SI-B001/CC-E/H3101
- Keywords
- Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Esophageal cancer, Colorectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Oct 2020 (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.
In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001.
In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.
In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of SI-B001 in patients with locally advanced or metastatic epithelial tumors will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Drug: SI-B001Participants receive SI-B001 as intravenous infusion for the first cycle (4 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must sign the informed consent form voluntarily and follow the plan requirements.
- No gender limit.
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).
- Expected survival time ≥ 3 months.
- Locally advanced or metastatic epithelial malignancies are confirmed by histopathology and/or cytology that are incurable or currently without standard treatment.
Key exclusion criteria (16 listed)
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2weeks prior to the first administration.
- If there is a history of vaccination within 3 months prior to the first administration, it is allowed to receive inactivated influenza vaccine within 30 days prior to the first administration, and the treatment of live attenuated vaccine is not allowed.
- Participants with history of severe heart disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc.
- Participants with prolonged QT interval (male QTc> 450 msec or female QTc> 470 msec), complete left bundle branch block, III grade atrioventricular block.
- Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type I diabetes, hypothyroidism that can be controlled only by alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).
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-B001Administration by intravenous infusion. | Drug | Study treatment |
Primary outcome
Phase Ia: Dose limiting toxicity (DLT)
Time frame: Up to 28 days after the first dose of SI-B001
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle (28 days) 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.
Phase Ia: Maximum tolerated dose (MTD)
Time frame: Up to 28 days after the first dose of SI-B001
MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle (within 28 days of the first administration).
Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: Up to 28 days after the first dose of SI-B001
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-B001.
14 secondary outcomes
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to 28 days after the first dose of SI-B001
Tmax
Time frame: Up to 28 days after the first dose of SI-B001
T1/2
Time frame: Up to 28 days after the first dose of SI-B001
AUC0-t
Time frame: Up to 28 days after the first dose of SI-B001
CL (Clearance)
Time frame: Up to 28 days after the first dose of SI-B001
Ctrough
Time frame: Up to 28 days after the first dose of SI-B001
ADA (anti-drug antibody)
Time frame: Up to approximately 24 months
Nab (neutralizing antibody)
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Overall survival
Time frame: Up to approximately 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 26 Sep 2025.
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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. This study is not recruiting at the moment.
Li Zhang principal investigator
Sun Yat-sen University
3 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-B001 in people with Locally Advanced or Metastatic Epithelial Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 sites 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 14 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Dose limiting toxicity (DLT) (time frame: Up to 28 days after the first dose of SI-B001). 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?
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 26 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.