AzTrials
AzTrials

Urinary System TumorPhase 2NCT05785039

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors

A Phase 2 study testing BL-B01D1 in people with Urinary System Tumor 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
Search all trials

Trial summary

Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Urinary System Tumor, Solid Tumor
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
76 participants
Where
1 siteChina
Study dates
20 Apr 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

  • Sign the informed consent form voluntarily and follow the protocol requirements;
  • Gender is not limited;
  • Age: ≥18 years old and ≤75 years old;
  • Expected survival time ≥3 months;
  • Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which standard treatment is currently unavailable or unavailable;
  • Testosterone levels in prostate cancer \< 1.73 nmol/L (50 ng/dL), disease progression before screening, according to the PCWG3 consensus;
Show all 13Show fewer
  • Agree to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years. If the subjects cannot provide tumor tissue samples, they can be enrolled after the evaluation of the investigators if they meet other inclusion and exclusion criteria;
  • At least one measurable lesion (other than prostate cancer), as defined by RECIST v1.1, was required;
  • ECOG 0 or 1;
  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • With adequate organ function;
  • For premenopausal women who are likely to have children, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Who cannot join

  • Antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil drugs;
  • History of severe cardiovascular and cerebrovascular diseases;
  • Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
  • Active autoimmune and inflammatory diseases;
  • Other malignant tumors that progressed or required treatment within 5 years before the first dose;
  • Patients with poor blood glucose control before the first dose;
Show all 24Show fewer
  • Hypertension poorly controlled with two antihypertensive drugs before the first dose or previous history of hypertensive crisis or hypertensive encephalopathy;
  • A history of interstitial lung disease (ILD), current ILD, or suspicion of such disease on imaging during screening;
  • Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
  • Were receiving \&gt before the first dose; Long-term systemic corticosteroid therapy with 10mg/ day prednisone or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
  • Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases) and/or spinal cord compression;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Imaging examination indicated that the tumor had invaded or wrapped the large blood vessels of the chest, neck, and pharynx, except that the investigator thought that it would not affect the patient's enrollment in the drug;
  • Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;
  • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
  • Had a serious infection within 4 weeks before the first dose of study drug; Indications of active pulmonary infection within 2 weeks before the first dose of study drug;
  • Patients with superior vena cava syndrome should not be rehydrated;
  • Had a history of severe neurological or psychiatric disorders;
  • Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
  • Serious unhealed wounds, ulcers, or fractures, or clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
  • Subjects scheduled to receive live vaccine or within 28 days before the first dose;
  • 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.

Sa Xiao, PHD contact

+86-15013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Fudan University ShangHai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye, PHD

    Recruiting

Other trials in China

About this study

Official title: Phase IIa/IIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors

Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors.

Read the detailed description

Phase IIa: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors such as locally advanced or metastatic urinary system tumors, and further determine RP2D. The preliminary efficacy, pharmacokinetic characteristics and immunogenicity of BL-B01D1 were evaluated. Phase IIb: To explore the efficacy of BL-B01D1 as a single agent RP2D obtained in a Phase IIa clinical study. To evaluate the safety and tolerability, pharmacokinetic characteristics and immunogenicity of BL-B01D1.

Being tested
BL-B01D1
Medical subject headings
Urologic 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 NCT05785039
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants 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.

  1. Phase IIa: 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 approximately 24 months

  2. Phase IIb: 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

Secondary outcomes (12)

  1. Phase IIa/IIb: 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

  2. Phase IIa: 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

  3. Phase IIb: 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

  4. Phase IIa/IIb: 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

  5. Phase IIa/IIb: 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

  6. Phase IIa/IIb: Cmax

    Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  7. Phase IIa/IIb: Tmax

    Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  8. Phase IIa: T1/2

    Half-life (T1/2) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  9. Phase IIa: AUC0-t

    Blood concentration - Area under time line.

    Measured: Up to approximately 24 months

  10. Phase IIa: CL

    To study the serum clearance rate of BL-B01D1 per unit time.

    Measured: Up to approximately 24 months

  11. Phase IIa/IIb: Ctrough

    Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  12. Phase IIa/IIb: Anti-drug antibody (ADA)

    Frequency and titer of anti-BL-B01D1 antibody (ADA) will be evaluated.

    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 posted27 Mar 2023
  2. Study start20 Apr 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785039
Sponsor's protocol ID
BL-B01D1-201
Status last verified
Aug 2026
First submitted
9 Mar 2023
Last updated
27 Aug 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 2 study testing BL-B01D1 in people with Urinary System Tumor 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 13 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 27 Aug 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 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 (+86-15013238943, 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 IIa: Recommended Phase II Dose (RP2D) (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?

On the ClinicalTrials.gov record for NCT05785039.

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 27 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in