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Bladder CancerPhase 2NCT04718584

the Efficacy and Safety of LDP in Patients With Urinary and Male Genital Tumors

A Phase 2 study testing Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in people with Bladder Cancer and Renal Carcinoma, run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-arm,open, multicenter, phase II clinical study of the efficacy and safety of human anti-PD-L1 monoclonal antibody Injection (LDP) in the treatment of urinary and male genital tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
11 Sep 2020to 27 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age ≥ 18 (inclusive), ≤18 (inclusive)
  • Patients with muscular-infiltrating bladder cancer suitable for surgery; advanced opaque cell renal carcinoma; advanced penile carcinoma
  • The estimated survival time is more than 3 months.
  • At least one assessable tumor lesion according to RECIST1.1 (in cohort 1, evaluate lesion is accept);
  • ECOG physical strength score 0-1;
  • Enough organ function: Blood routine (no blood transfusion or colony stimulating factor (G-CSF) treatment within 14 days):ANC≥1.5×109 / L, PLT≥75×109 / L, Hb≥80g/L; Liver function: TBIL≤1.5×ULN, ALT≤2.5×ULN, AST≤2.5×ULN (ALT,AST≤5×ULN for liver metastasis patients); Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance > 50 ml /min(according to Croft Gault formula) ; Coagulation function: APTT≤ 1.5 ×ULN, PT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN;
  • Eligible patients (male and female) with fertility must agree to use reliable methods of contraception (hormone or barrier or abstinence) during the trial period and at least 6 months after the last dose; The blood or urine pregnancy test within 7 day before being selected must be negative for the female patients of childbearing age;
  • Subjects must give informed consent to this study before the study, and voluntarily sign a written informed consent;

Who cannot join

  • Received radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first administration, or other unlisted clinical trial drug therapy (mitomycin and nitrosourea are 6 weeks from the last administration, oral fluorouracil drugs such as Tegiol and Capecitabine are at least 2 weeks from the last administration, small molecule targeted drugs are at least 2 weeks or at least interval 5 half-life (Subject to the longer time) from the last administration, and traditional Chinese medicine with antitumor indications are at least 2 weeks from the last administration.
  • Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks prior to the first administration.
  • The adverse effects of previous antitumor therapy have not recovered to CTCAE 5.0 ≤grade1 (except for alopecia)
  • Patients with clinical symptoms of brain metastases, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastases are not suitable for inclusion as judged by the investigator
  • Patients who had previously received PD-1 or PD-L1 inhibitors;
  • Immunorelated adverse events ≥ Grade 3 were observed in previous immunotherapy except for PD-1 or PD-L1 inhibitors;
Show all 18Show fewer
  • Patients have any active autoimmune diseases or a history of autoimmune diseases (e.g., but not limited to: systemic lupus erythematosus, autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo, etc.); Complete remission of asthma in childhood can be included if in adults without any intervention;Asthma patients requiring bronchodilators for medical intervention were excluded);
  • Patients who received systemic corticosteroid (prednisone > 10mg/ day or equivalent) or other immunosuppressive therapy within 14 days prior to initial dosing; Exceptions include: topical, ocular, intraarticular, intranasal, and inhaled corticosteroids;Short-term use of corticosteroids for preventive treatment, such as before the use of contrast agents;
  • Malignancies that were active within the last 2 years prior to initial administration (except for the tumors targeted in this study);
  • Uncontrolled active hepatitis B (HBsAg positive with HBV DNA copy number > 103/ mL or HBV DNA titer >200 IU/ mL); Hepatitis C;
  • Syphilis infection (syphilis antibody positive) and HIV positive patients.
  • A history of serious cardiovascular disease, including ventricular arrhythmias requiring clinical intervention;Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months;New York Heart Association (NYHA) cardiac function grade ≥II or left ventricular ejection fraction (LVEF) < 50%;Patients with clinically uncontrolled hypertension who are not suitable for the trial as determined by the investigator;
  • Patients with a history of other serious systemic diseases who have been determined by the investigator to be unsuitable for participation in clinical trials;
  • Known alcohol or drug dependence;
  • Mental disorder or poor compliance;
  • Women who are pregnant or lactating;
  • Have received live attenuated vaccine within 4 weeks before the first administration or scheduled to receive during the study period.
  • The Investigator considers that the subject is unsuitable to participate in this study because of any clinical or laboratory test abnormalities or other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dragonboat Biopharmaceutical,Co.,Ltd

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Single-arm, Open, Multicenter, Phase II Clinical Study of the Efficacy and Safety of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in the Treatment of Urinary and Male Genital Tumors

This is a single-arm,open, multicenter, phase II clinical study of the efficacy and safety of human anti-PD-L1 monoclonal antibody Injection (LDP) in the treatment of urinary and male genital tumors.

Read the detailed description

This trial is a single arm, open, multicenter, Ⅱ period clinical research. Three cohorts were included, 127 subjects were enrolled (Cohort 1: about 60 subjects with surgically suitable muscular-invasive bladder cancer; Cohort 2: about 40 subjects with advanced Non-clear Cell Renal Carcinoma; Cohort 3: about 27 subjects with advanced penile carcinoma. After confirmation of inclusion, intravenous infusion of 10mg/kg human anti-PD-L1 monoclonal antibody injection (LDP) was given. The initial efficacy and safety of drugs in different tumor species in the cohort above will be observed.

Being tested
Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Renal Cell

What participants receive

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

  • Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)Drug

    Also called LDP

    All participants will receive treatment with LDP 10mg/kg once every two weeks, every 2 weeks will be a cycle. In Cort 1, surgical treatment will be performed within 2 weeks after the end of 3 cycles of treatment.

Study groups in NCT04718584
Study groupRoleWhat they receive
Experimental ArmsExperimentalAll participants will receive treatment with LDP 10mg/kg once every two weeks, every 2 weeks will be a cycle. In Cort 1, surgical treatment will be performed within 2 weeks after the end of 3 cycles of treatment.
Receives: Drug: Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)

What is being measured

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

  1. Case complete response （pCR）

    The pCR is defined as the case complete response in Cohort 1 (muscular-infiltrating bladder cancer suitable for surgery)

    Measured: At the end of the cycle 3 of treatment (each cycle is 14 days).

  2. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 in Cohort 2 (Non-clear Cell Renal cell Carcinoma) and Cohort 3 (advanced penile carcinoma)

    Measured: From first dose of LDP through 21 days after last dose of LDP up to 2 years.

Secondary outcomes (11)

  1. Recurrence-free survival (RFS)

    Recurrence-free survival (RFS) is defined as the time from the start of surgery to the earliest evidence of recurrence.

    Measured: One year after surgery or disease progression or intolerant toxicity, up to 2 years.

  2. Progression-free survival （PFS）

    Progression-free survival (PFS) is defined as the time elapsed from the day the study drug was first administered until the first imaging assessment of disease progression (PD) or death from any cause.

    Measured: From first dose of LDP, up to 2 years.

  3. Disease control rate (DCR)

    Disease control rate (DCR) is defined as the proportion of the optimal time response of CR, PR, disease stable (SD) (i.e. CR+PR+SD) between initiation of the trial drug and withdrawal from the trial, as assessed according to RECIST1.1 criteria.

    Measured: From first dose of LDP, up to 2 years.

  4. Duration of response (DOR)

    The duration of response (DOR) is defined as the time from the beginning of the first tumor assessment as PR or CR to the first assessment as PD or death from any cause.

    Measured: From first dose of LDP, up to 2 years.

  5. Overall survival (OS)

    Overall survival (OS) is defined as the time between the date of first use of the study drug and death from any cause.

    Measured: From first dose of LDP, up to 2 years.

  6. Incidence of adverse events

    Adverse events (AEs) refer to all adverse medical events that occur when subjects sign the informed consent, which may be manifested as symptoms, signs, diseases or abnormal laboratory tests, but not necessarily causally related to the investigational drug.

    Measured: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.

  7. Incidence of abnormal vital signs

    Vital signs (including temperature, respiration, heart rate and blood pressure) can be measured. The time window for each vital sign measurement is ±10 minutes.

    Measured: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.

  8. Incidence of abnormal ECOG scores

    ECOG physical strength rating is based on ECOG physical strength rating criteria.

    Measured: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.

  9. Incidence of abnormal laboratory tests results

    Descriptive analysis of laboratory results for safety analysis.

    Measured: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.

  10. Incidence of abnormal physical examinations

    Descriptive analysis of physical examination for safety analysis.

    Measured: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.

  11. anti-drug antibody (ADA)

    Anti-drug antibody (ADA) is tested for immunogenicity assessment , titer and neutralizing antibody analysis were performed when ADA was positive, and immunocomplex (CIC) and complement analysis were performed.

    Measured: In Cohort 1: before administration ,before surgery; In Cohort 2, 3: before administration, up to 4 months.

Timeline

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

  1. First posted22 Jan 2021
  2. Study start11 Sep 2020
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 2024

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718584
Sponsor's protocol ID
LDP-II-01
Status last verified
Feb 2024
First submitted
13 Jan 2021
Last updated
6 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in people with Bladder Cancer and Renal Carcinoma, run by Dragonboat Biopharmaceutical Company Limited 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 6 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Case complete response （pCR） (time frame: At the end of the cycle 3 of treatment (each cycle is 14 days).). 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 NCT04718584.

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 6 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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