Urothelial CarcinomaPhase 2NCT05965856
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
A Phase 2 study testing BL-B01D1 and SI-B003 in people with Urothelial Carcinoma and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This phase II study is designed to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urothelial Carcinoma, Solid Tumor
- What is being tested?
- BL-B01D1 and SI-B003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2023to Dec 2027
- Phase
- Phase 2
- 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
- All subjects voluntarily participated in the study and signed informed consent;
- Male or female aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- ECOG 0-1;
- Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology who have failed or cannot tolerate standard treatment or who currently have no standard treatment or cannot obtain standard treatment; (including but not limited to urothelial cancer, prostate cancer, kidney cancer) : ① Urothelial cancer should have received previous failure or intolerance to standard platinum-based chemotherapy; ② Prostate cancer with pathological type of adenocarcinoma should have received at least one previous novel hormonal therapy (abiraterone acetate, enzalutamide, etc.) and at least one failed or intolerant taxane regimen (docetaxel, cabazitaxel); ③ Clear cell renal cell carcinoma required previous failure or intolerance to standard first-line tyrosine kinase inhibitor (TKI) regimens. ④ Locally advanced or metastatic other urological malignancies (non-clear cell renal cancer, penile cancer, etc.) that failed standard treatment and were not suitable for surgery or radiotherapy. Treatment failure was defined as disease progression during or after treatment with systemic antitumor regimens. Intolerance refers to patients who have received standard treatment and have grade 3-4 adverse reactions, and refuse to continue the original regimen.
- Note: Recurrence or disease progression within 6 months of the last chemotherapy in multimodal therapy was considered as first-line treatment.
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- Consent to provide archival tumor tissue specimens (10 unstained sections (anti-slip) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If participants cannot provide tumor tissue samples, they can be enrolled if they meet other inclusion and exclusion criteria, after the evaluation of the investigator;
- Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions that had been previously treated with radiation could be included in a measurable lesion only if there was definite disease progression after radiation therapy.
- Provided that no blood transfusions and no use of any cell growth factors and/or platelet-raising agents are allowed for 14 days prior to the screening period, organ function levels must meet the following criteria:
- Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L;
- Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥40 mL/min (according to Cockcroft and Gault formula).
- Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both ≤5.0 ULN when liver metastasis was present;
- Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN;
- no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;
- Toxicity from previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (asymptomatic laboratory abnormalities such as ALP elevation, hyperuricemia, and hyperglycemia were considered by the investigator, and toxicity with no safety risk was judged by the investigator; Except for alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin ≥90g/L).
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
Who cannot join
- Previous use of an ADC drug with a topoisomerase I inhibitor as a toxin;
- Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose Physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including Small molecule tyrosine kinase inhibitors) and other anti-tumor therapy; Mitomycin and nitrosoureas were given for the first time Within 6 weeks before treatment; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy for Within 2 weeks before the first dose; No exposure to wide-field radiotherapy within 4 weeks before study treatment for prostate cancer (tired) And ≥30% bone marrow), samarium must be completed 4 weeks prior to the first dose of treatment, and strontium and Lu 177 treatment This must be completed at least 12 weeks before the first administration of treatment, and radium-233 must precede the first administration of treatment At least 6 weeks to complete. Prostate cancer bone metastasis therapy such as bisphosphonates or denosumab should be administered before the first dose It was initiated at 4 weeks and was administered at a stable dose.
- Patients with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis must be excluded;
- Use of immunomodulatory drugs within 14 days before the first use of the study drug, including but not limited to thymosin, Interleukin-2, interferon, etc. must be excluded;
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias or grade III atria requiring clinical intervention Ventricular block;
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- prolonged QT interval at rest (QTc > 450 msec in men or QTc > 470 msec in women);
- cerebrovascular accident or transient ischemic attack within 6 months before the first dose; Symptomatic congestive History of heart failure (CHF) ≥ grade 2 (CTCAE 5.0) and New York Heart Association (NYHA) ≥ Grade 2 heart failure, transmural myocardial infarction history, unstable angina, etc.
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, requiring systemic treatment Psoriasis, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., excluding type I sugar Urinary disorders, hypothyroidism that can be controlled with replacement therapy alone, skin disorders that do not require systemic treatment (e.g Vitiligo and psoriasis).
- Systemic corticosteroids (> 10mg/ day prednisone, or equivalent) are required within 2 weeks before the study dose Doses of other corticosteroids) or immunosuppressive agents; Inhaled or topical administration of hormones, or due to adrenal The exception is those who were treated with physiological replacement doses of hormone for insufficiency;
- Other malignancies that progressed or required treatment within 5 years before the first dose, such as the following External: radical resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, radical resection of carcinoma in situ, such as breast carcinoma in situ, prostate cancer; Remarks: Localized low-risk prostate cancer (Defined as stage ≤T2a, Gleason score ≤6, and PSA < 10ng/mL at prostate cancer diagnosis (e.g Measured) had received curative treatment and had no PSA biochemical recurrence Were eligible to participate in this study);
- History of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation requiring steroid therapy, or when Patients with previous ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that could not be excluded by imaging at the time of screening Syndrome;
- Prior to starting the study treatment, there are:
- Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)
- Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- History of hypertensive crisis or hypertensive encephalopathy
- Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening Thrombotic events such as plug; Infusion-related thrombosis was excluded.
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). But he had a brain turn Metastatic therapy (radiotherapy or surgery; And the subjects had stopped radiotherapy and surgery 2 weeks before the first dose.) Patients with stable brain metastases less than 10mm in diameter were eligible for enrollment Patients (with leptomeningeal metastases) were excluded even if they were treated and judged to be stable.
- Patients with large amount of serous cavity effusion, or serous cavity effusion with symptoms, or before signing informed consent Patients who underwent drainage within 4 weeks;
- Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to BL-B01D1, SI-B003 Patients who are allergic to excipients;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus Infection (HBV-DNA copy number > 103 IU/ml) or active hepatitis C virus infection (anti-HCV Body positive and HCV-RNA > detection limit).
- Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- Participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
- Persons who have a history of psychotropic drug abuse and cannot be abstinent or have mental disorders;
- Any other circumstances that the investigator deemed inappropriate for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Dingwei Ye
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
This phase II study is designed to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.
- Conditions
- Urothelial Carcinoma, Solid Tumor
- Being tested
- BL-B01D1, SI-B003
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
Administration by intravenous infusion
SI-B003Drug
Administration by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1 + SI-B003 | Experimental | Participants receive SI-B003 or BL-B01D1+SI-B003 dual therapy in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons. Receives: Drug: BL-B01D1; Drug: SI-B003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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-B003.
Measured: Up to approximately 24 months
Secondary outcomes (4)
Progression-free survival (PFS)
The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.
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
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
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 posted28 Jul 2023
- Study start11 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, PHD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965856
- Sponsor's protocol ID
- BL-B01D1-SI-B003-201-06
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2023
- 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 II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT05965856
- Acronym / sponsor ID
- BL-B01D1-SI-B003-201-06
- Conditions
- Urothelial Carcinoma, Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jul 2023 (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.
This phase II study is designed to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1 + SI-B003 | Experimental | Drug: BL-B01D1, Drug: SI-B003Participants receive SI-B003 or BL-B01D1+SI-B003 dual therapy in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All subjects voluntarily participated in the study and signed informed consent;
- Male or female aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- ECOG 0-1;
- Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology who have failed or cannot tolerate standard treatment or who currently have no standard treatment or cannot obtain standard treatment; (including but not limited to urothelial cancer, prostate cancer, kidney cancer) : ① Urothelial cancer should have received previous failure or intolerance to standard platinum-based chemotherapy; ② Prostate cancer with pathological type of adenocarcinoma should have received at least one previous novel hormonal therapy (abiraterone acetate, enzalutamide, etc.) and at least one failed or intolerant taxane regimen (docetaxel, cabazitaxel); ③ Clear cell renal cell carcinoma required previous failure or intolerance to standard first-line tyrosine kinase inhibitor (TKI) regimens. ④ Locally advanced or metastatic other urological malignancies (non-clear cell renal cancer, penile cancer, etc.) that failed standard treatment and were not suitable for surgery or radiotherapy. Treatment failure was defined as disease progression during or after treatment with systemic antitumor regimens. Intolerance refers to patients who have received standard treatment and have grade 3-4 adverse reactions, and refuse to continue the original regimen.
Key exclusion criteria (26 listed)
- Previous use of an ADC drug with a topoisomerase I inhibitor as a toxin;
- Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose Physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including Small molecule tyrosine kinase inhibitors) and other anti-tumor therapy; Mitomycin and nitrosoureas were given for the first time Within 6 weeks before treatment; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy for Within 2 weeks before the first dose; No exposure to wide-field radiotherapy within 4 weeks before study treatment for prostate cancer (tired) And ≥30% bone marrow), samarium must be completed 4 weeks prior to the first dose of treatment, and strontium and Lu 177 treatment This must be completed at least 12 weeks before the first administration of treatment, and radium-233 must precede the first administration of treatment At least 6 weeks to complete. Prostate cancer bone metastasis therapy such as bisphosphonates or denosumab should be administered before the first dose It was initiated at 4 weeks and was administered at a stable dose.
- Patients with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis must be excluded;
- Use of immunomodulatory drugs within 14 days before the first use of the study drug, including but not limited to thymosin, Interleukin-2, interferon, etc. must be excluded;
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
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 |
|---|---|---|
| BL-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507Administration by intravenous infusion | Drug | BL-B01D1 + SI-B003 |
| SI-B003Administration by intravenous infusion | Drug | BL-B01D1 + SI-B003 |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 24 months
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.
Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
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-B003.
4 secondary outcomes
Progression-free survival (PFS)
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
Treatment-Emergent Adverse Event (TEAE)
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.
Dingwei Ye, PHD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL-B01D1 and SI-B003 in people with Urothelial Carcinoma 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 16 inclusion and 26 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 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Objective response rate (ORR) (time frame: Up to approximately 24 months). The study lists 2 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.