Experimental immunotherapy targets tough urinary cancers
NCT ID NCT04718584
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase 2 trial tests an experimental drug called LDP, an anti-PD-L1 monoclonal antibody that helps the immune system attack cancer cells. It enrolls adults with muscle-invasive bladder cancer, non-clear cell kidney cancer, or advanced penile cancer. Participants receive LDP infusions every two weeks, and researchers measure how many tumors shrink or disappear, as well as safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-PD-L1 monoclonal antibody (LDP)
- What this could lead to
- If successful, this could offer a new treatment option for certain hard-to-treat urinary and male genital cancers.
- What could go wrong
- This is an early-phase trial with only 27 participants, so results may not apply broadly. The drug may cause immune-related side effects or fail to shrink tumors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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27 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Feb 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 (inclusive), ≤18 (inclusive) 2. Patients with muscular-infiltrating bladder cancer suitable for surgery; advanced opaque cell renal carcinoma; advanced penile carcinoma 3. The estimated survival time is more than 3 months. 4. At least one assessable tumor lesion according to RECIST1.1 (in cohort 1, evaluate lesion is accept); 5. ECOG physical strength score 0-1; 6. 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; 7. 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; 8. Subjects must give informed consent to this study before the study, and voluntarily sign a written informed consent; Exclusion Criteria: 1. 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. 2. Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks prior to the first administration. 3. The adverse effects of previous antitumor therapy have not recovered to CTCAE 5.0 ≤grade1 (except for alopecia) 4. 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 5. Patients who had previously received PD-1 or PD-L1 inhibitors; 6. Immunorelated adverse events ≥ Grade 3 were observed in previous immunotherapy except for PD-1 or PD-L1 inhibitors; 7. 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); 8. 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; 9. Malignancies that were active within the last 2 years prior to initial administration (except for the tumors targeted in this study); 10. Uncontrolled active hepatitis B (HBsAg positive with HBV DNA copy number \> 103/ mL or HBV DNA titer \>200 IU/ mL); Hepatitis C; 11. Syphilis infection (syphilis antibody positive) and HIV positive patients. 12. 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; 13. Patients with a history of other serious systemic diseases who have been determined by the investigator to be unsuitable for participation in clinical trials; 14. Known alcohol or drug dependence; 15. Mental disorder or poor compliance; 16. Women who are pregnant or lactating; 17. Have received live attenuated vaccine within 4 weeks before the first administration or scheduled to receive during the study period. 18. The Investigator considers that the subject is unsuitable to participate in this study because of any clinical or laboratory test abnormalities or other reasons.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
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Other studies related to the condition(s) this trial covers.
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