- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739111
An Exploratory Clinical Study of LDP Combined With CDP1 in Patients With Advanced Malignant Tumor
February 3, 2021 updated by: Dragonboat Biopharmaceutical Company Limited
An Exploratory Clinical Study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined With Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Malignant Tumor
This is an exploratory clinical study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in patients with advanced malignant tumor.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This is an open, dose-escalation and dose-extension exploratory clinical study for patients with advanced malignancy who have failed standard therapy.
In the dose-escalation phase, a fixed dose of CDP1 will be given once a week, while LDP will be given every two weeks with dose climbing.
Then, cohort studies (cohorts 1 to 5) will be conducted during the dose-expansion phase.
The purpose is to preliminarily evaluate the safety and efficacy of LDP combined with CDP1 in the treatment of patients with advanced malignant tumor, and to determine the recommended dose for clinical trial.
Study Type
Interventional
Enrollment (Anticipated)
130
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wenli Ji
- Phone Number: #86#021-50276381-637
- Email: wenli.ji@dragonboatbio.com
Study Contact Backup
- Name: Zhen Jin
- Phone Number: #86#021-50276381
- Email: zhen.jin@dragonboatbio.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Dragonboat Biopharmaceutical,Co.,Ltd
-
Contact:
- Wenli Ji
- Phone Number: #86#021-50276381-637
- Email: wenli.ji@dragonboatbio.com
-
Contact:
- Zhen Jin
- Phone Number: #86#021-50276381
- Email: zhen.jin@dragonboatbio.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. Age ≥ 18 (inclusive), no gender limitation;
- 2. The estimated survival time is more than 3 months.
- 3. At least one assessable tumor lesion according to RECIST1.1 (in cohort 1, evaluate lesion is accept);
- 4. ECOG physical strength score 0-2;
- 5. No serious abnormal blood system, liver function, kidney function or coagulation function: ANC≥1.5×109 / L, PLT≥75×109 / L, Hb≥9g/dL; TBIL≤1.5×ULN, ALT≤2.5×ULN, AST≤2.5×ULN; Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 50 ml /min(according to Croft Gault formula),Urinary protein ≤2+;or 24-hour urinary protein ≤1g; APTT≤ 1.5 ×ULN, PT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN;"
- 6.Blood or urine pregnancy tests are negative in women of childbearing age within 7 days before the first dose.Male subjects and female subjects of reproductive age must use adequate contraception and have no plans to donate sperm or eggs within 3 months from the date of signing informed consent for the study to the date of the last study drug treatment.
- 7. Subjects must give informed consent to this study before the study, and voluntarily sign a written informed consent;
- 8.Locally advanced or metastatic malignancies diagnosed by histopathology, which have failed standard treatment, have no standard treatment regimen, or are not suitable for standard treatment at this stage. In the dose-expansion phase: cohort 1: head and neck squamous cell carcinoma;Cohort 2: colorectal cancer, RAS genotype was wild type;Cohort 3: esophageal squamous cell carcinoma;Cohort 4: Penile cancer;Cohort 5: Female reproductive system tumors (endometrial, cervical, ovarian).
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 or anti-EGFR monoclonal antibody or other immune checkpoint inhibitors and failed;
- 6. Immunorelated adverse events ≥ Grade 3 were observed in previous immunotherapy;
- 7. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, interstitial lung disease, etc.);
- 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;
- 9. 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.
- 10. 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;
- 11. Known alcohol or drug dependence;
- 12. Mental disorder or poor compliance;
- 13. Women who are pregnant or lactating;
- 14. Have received live attenuated vaccine within 4 weeks before the first administration or scheduled to receive during the study period.
- 15. The Investigator considers that the subject is unsuitable to participate in this study because of any clinical or laboratory test abnormalities or other reasons.
- 16.A malignant tumor that has been active in the past two years (Except for tumors in this study, cured stage Ib cervical cancer or lower, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete response (CR) > for 10 years, and other malignant tumors with complete response (CR) BBB>r 5 years)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Arms
All participants will receive treatment with LDP combined with CDP1.
In the dose-escalation phase, a fixed dose of CDP1 will be given once a week, while LDP will be given every two weeks with dose climbing.
Then, cohort studies (cohorts 1 to 5) will be conducted during the dose-expansion phase.
|
In the dose-escalation phase, CDP1 400 mg/ m2 will be given in the first week, then 250 mg/m2 will be given evert week.
LDP will be given every two weeks with dose climbing of 5 mg/kg, 10 mg/kg, 20 mg/kg.
Dose in the dose-expansion phase according to the assesment in the dose-escalation phase.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: From first dose of LDP combined of CDP1 through 30 days after last dose, up to 5 months.
|
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.
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From first dose of LDP combined of CDP1 through 30 days after last dose, up to 5 months.
|
Dose Limiting Toxicities (DLT)
Time Frame: Time Frame: 28 days after first dose of LDP combined of CDP1, up to 24 months.
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Number of participants with dose limiting toxicity (DLT)
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Time Frame: 28 days after first dose of LDP combined of CDP1, up to 24 months.
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Recommended dose for clinical trials
Time Frame: up to 24 months
|
A comprehensive evaluation of the results from the dose escalation/expansion phase was conducted to determine the recommended dose for the clinical trial.
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up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: From first dose of LDP combined of CDP1, up to 2 years.
|
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
|
From first dose of LDP combined of CDP1, up to 2 years.
|
Duration of response (DOR)
Time Frame: From first dose of LDP combined of CDP1, an average of 6 months.
|
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.
|
From first dose of LDP combined of CDP1, an average of 6 months.
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Disease control rate (DCR)
Time Frame: From first dose of LDP combined of CDP1, up to 2 years.
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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
|
From first dose of LDP combined of CDP1, up to 2 years.
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Progression-free survival (PFS)
Time Frame: From first dose of LDP combined of CDP1, an average of 6 months.
|
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.
|
From first dose of LDP combined of CDP1, an average of 6 months.
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Maximum plasma concentrations (Cmax)
Time Frame: an average of 6 months
|
Pharmacokinetic parameter, Observed Maximum Serum Concentration (Cmax) of LDP and CDP1.
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an average of 6 months
|
Area under the plasma concentration-time curve from zero to last concentration time (AUC0-t)
Time Frame: an average of 6 months
|
Pharmacokinetic Parameters, Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of LDP and CDP1.
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an average of 6 months
|
Half-life (t1/2)
Time Frame: an average of 6 months
|
Pharmacokinetic parameters,Apparent Terminal Half-life (t1/2) of LDP and CDP1.
|
an average of 6 months
|
anti-drug antibody (ADA)
Time Frame: an average of 6 months
|
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.
|
an average of 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Yongsheng Wang, West China Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 29, 2021
Primary Completion (ANTICIPATED)
February 1, 2023
Study Completion (ANTICIPATED)
February 1, 2024
Study Registration Dates
First Submitted
February 1, 2021
First Submitted That Met QC Criteria
February 1, 2021
First Posted (ACTUAL)
February 4, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2021
Last Update Submitted That Met QC Criteria
February 3, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCSW-LDP+CDP1-Ⅰ-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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