Overview

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

Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dragonboat Biopharmaceutical Company Limited
Collaborator:
Fudan University
Treatments:
Antibodies
Antibodies, Monoclonal
Criteria
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.