Locally Advanced or Metastatic Urinary TumorsPhase 1NCT05393427

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors

A Phase 1 study testing BL-B01D1 in people with Locally Advanced or Metastatic Urinary Tumors and Other Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 4 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic urinary tumors and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Locally Advanced or Metastatic Urinary Tumors, Other Solid Tumors
What is being tested?: BL-B01D1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 4 sitesChina
Study dates: 15 Feb 2022to 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 to 75 years
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 tumors of the urinary system and other solid tumors confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment. Intolerance refers to the occurrence of grade 3-4 adverse reactions after a patient has received standard treatment, and the patient refuses to continue the original treatment;
Agree to provide archived tumor tissue specimens (10 unstained sections (anti-extraction) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If patients cannot provide such specimens, they can be included in the group after the judgment of the investigator if other inclusion criteria are met;

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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 antitumor therapy was restored to ≤ class 1 as defined by NCI-CTCAE v5.0 (the investigators considered asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated blood glucose, etc., and toxicities that the investigators judged to be of no safety risk, except for alopecia and grade 2 peripheral neurotoxicity);
No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%;
The organ function must meet the following requirements and standards: a) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥75×109/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;
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;
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
Have serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias and ⅲ degree ATrioventricular block requiring clinical intervention;
QT interval was prolonged in resting state (QTc > 450 msec for men or 470 msec for women);
Myocardial infarction, unstable angina, cardiac angioplasty or stent implantation, coronary artery/peripheral artery bypass graft, Class ⅲ or ⅳ congestive heart failure, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first administration;
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);

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Other malignant tumors were diagnosed within 2 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;
Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD);
Screening for unstable deep vein thrombosis, arterial thrombosis, and pulmonary thrombus requiring therapeutic intervention within the first 6 months Thrombotic events such as stoppage; Thrombus formation associated with infusion set is excluded;
Symptoms of active central nervous system metastasis. However, patients with stable brain parenchymal metastases can be enrolled. stable Was defined as: a. duration > 3 months without seizure with or without antiepileptic drugs; b. Have central nervous system (CNS) metastatic and/or cancerous meningitis. He was treated for brain metastases Patients with stable disease for at least 3 months underwent imaging within 28 days before first receiving the study drug Examination determined that no disease progression had occurred and that all neurological symptoms had returned to ≤ grade 1 (CTCAE5.0) Or at baseline (other than signs or symptoms associated with CNS treatment) for at least 2 weeks with no evidence of occurrence Had new or expanded brain metastases and was treated with prednisone within 7 days before first receiving the study drug Patients with dose ≤20mg/ day (or equivalent) were included in this study. Cancer meningitis, regardless of clinical Whether the condition is stable or not should be ruled out;
Allergic history to recombinant humanized antibody or mouse chimeric antibody or BL-B01D1 excipients A sensitive patient;
Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
The cumulative dose of anthracyclines in previous adjuvant therapy was greater than 360 mg/m2;
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 (HCV anti Body positive and HCV-RNA > lower limit of detection);
Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
The other conditions of participation in this clinical trial were not considered appropriate by the investigators.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University First Hospital
Beijing, Beijing Municipality
West China Hospital, Sichuan University
Chengdu, Sichuan
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality

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 BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors

In phase Ib study, the safety and tolerability of BL-B01D1 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 BL-B01D1 in patients with locally advanced or metastatic urinary tumors and other solid tumors will be evaluated.

Conditions: Locally Advanced or Metastatic Urinary Tumors, Other Solid Tumors
Being tested: BL-B01D1
Keywords: Renal Carcinoma (RCC), Bladder Cancer (BC), Urothelial Cancer (UC), Other Solid Tumors
Medical subject headings: Carcinoma, Renal Cell, Urinary Bladder Neoplasms

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

Study groups in NCT05393427
Study group	Role	What they receive
Study treatment	Experimental	Participants receive BL-B01D1 as intravenous infusion 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: BL-B01D1

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 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
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
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 BL-B01D1
Measured: Up to 21 days after the first dose

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 BL-B01D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1 .
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.
Measured: Up to 21 days after the first dose
Tmax
Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.
Measured: Up to 21 days after the first dose
T1/2
Half-life (T1/2) of BL-B01D1 will be investigated.
Measured: Up to 21 days after the first dose
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 21 days after the first dose
CL (Clearance)
CL in the serum of BL-B01D1 per unit of time will be investigated.
Measured: Up to 21 days after the first dose
Ctrough
Ctough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.
Measured: Up to 21 days after the first dose
ADA (anti-drug antibody)
Incidence and titer of ADA of BL-B01D1 will be evaluated.
Measured: Up to approximately 24 months
Nab (neutralizing antibody)
Incidence and titer of Nab of BL-B01D1 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 BL-B01D1 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Overall Survival (OS)
The OS is defined as the time from randomization to 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.

15 Feb 2022Dec 2025

First posted26 May 2022
Study start15 Feb 2022
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 Urinary TumorsStudies 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: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05393427
Sponsor's protocol ID: BL-B01D1-102
Status last verified: Sep 2025
First submitted: 20 Feb 2022
Last updated: 26 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
DV Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer
Bladder Cancer
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
Active, not recruitingPhase 2
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Metastatic Urothelial Cancer
Not yet recruitingObservational study
A Real-world Study to Learn About of the Characteristics and Outcomes of Advanced or Metastatic Bladder Cancer Patients With Different Histologies
Metastatic Urothelial Carcinoma, Urothelial Cancer
RecruitingPhase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Advanced Solid Tumor, Melanoma

All Locally Advanced or Metastatic Urinary Tumors trials

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 BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors
ClinicalTrials.gov ID: NCT05393427
Acronym / sponsor ID: BL-B01D1-102
Conditions: Locally Advanced or Metastatic Urinary Tumors, Other Solid Tumors
Keywords: Renal Carcinoma (RCC), Bladder Cancer (BC), Urothelial Cancer (UC), Other Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 4 participants (actual)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: SystImmune Inc., Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study start: 15 Feb 2022 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 26 May 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study treatment	Experimental	Drug: BL-B01D1Participants receive BL-B01D1 as intravenous infusion 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 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 tumors of the urinary system and other solid tumors confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment. Intolerance refers to the occurrence of grade 3-4 adverse reactions after a patient has received standard treatment, and the patient refuses to continue the original 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;
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
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 2 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;
Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD);

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	Study treatment

Primary outcome

Phase Ia: Dose limiting toxicity (DLT)
Time frame: Up to 21 days after the first dose
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.
Phase Ia: Maximum tolerated dose (MTD)
Time frame: Up to 21 days after the first dose
MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.
Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: Up to 21 days after the first dose
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 BL-B01D1

14 secondary outcomes

Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to 21 days after the first dose
Tmax
Time frame: Up to 21 days after the first dose
T1/2
Time frame: Up to 21 days after the first dose
AUC0-t
Time frame: Up to 21 days after the first dose
CL (Clearance)
Time frame: Up to 21 days after the first dose
Ctrough
Time frame: Up to 21 days after the first dose
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 (OS)
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.

Related trials for Locally Advanced or Metastatic Urinary Tumors

Not yet recruitingPhase 1
DV Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer
Bladder Cancer
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
Active, not recruitingPhase 2
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Metastatic Urothelial Cancer
Not yet recruitingObservational study
A Real-world Study to Learn About of the Characteristics and Outcomes of Advanced or Metastatic Bladder Cancer Patients With Different Histologies
Metastatic Urothelial Carcinoma, Urothelial Cancer
RecruitingPhase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Advanced Solid Tumor, Melanoma

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.

Jun Guo, PHD principal investigator

Peking University Cancer Hospital & Institute

4 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 BL-B01D1 in people with Locally Advanced or Metastatic Urinary Tumors and Other Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 4 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 13 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 4 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 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 NCT05393427.

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.