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

NCT04718584 | Unknown Phase 2

• 1 other identifier: LDP-II-01
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer; Renal Carcinoma; Advanced Penile Carcinoma

Outcome Measures

Primary Outcomes (2)

• Case complete response （pCR）

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

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

• 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)

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

Secondary Outcomes (11)

• Recurrence-free survival (RFS)

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

• Progression-free survival （PFS）

  From first dose of LDP, up to 2 years.

• Disease control rate (DCR)

  From first dose of LDP, up to 2 years.

• Duration of response (DOR)

  From first dose of LDP, up to 2 years.

• Overall survival (OS)

  From first dose of LDP, up to 2 years.

Study Arms (1)

Experimental Arms

EXPERIMENTAL

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.

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

Interventions

Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) DRUG

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.

Also known as: LDP

Experimental Arms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 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;
• 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;

Sponsors & Collaborators

• Dragonboat Biopharmaceutical Company Limited: lead
• Fudan University: collaborator

Study Sites (1)

Dragonboat Biopharmaceutical,Co.,Ltd

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases

Study Officials

• Dingwei Ye

  Fudan University

  STUDY CHAIR

Central Study Contacts

Wenli Ji

CONTACT

#86#021-50276381-637; wenli.ji@dragonboatbio.com

Zhen Jin

CONTACT

#86#021-50276381; zhen.jin@dragonboatbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: September 11, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)