Phase I Clinical Trial of Human Anti-PD-L1 Antibody Injection (LDP) in Patients With Advanced Malignant Tumors

  • STATUS
    Recruiting
  • End date
    Apr 26, 2022
  • participants needed
    130
  • sponsor
    Dragonboat Biopharmaceutical Company Limited
Updated on 23 January 2021

Summary

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of LDP in subjects with advanced malignant tumors.

Description

This trial is an open, dose escalation phase I clinical trial study of patients with advanced cancer who have failed standard treatment. The trial is divided into a dose escalation phase and an expansion phase.

Approximately 130 patients will be enrolled in this trial. The dose-increasing phase is about 30 cases, and the expansion stage is about 100 cases.

Details
Condition Advanced Tumors
Treatment Whole Human Anti-PD-L1 Antibody Injection (LDP)
Clinical Study IdentifierNCT03908814
SponsorDragonboat Biopharmaceutical Company Limited
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Tumors?
Do you have any of these conditions: Do you have Advanced Tumors??
Age 18 (inclusive), regardless of gender
Histologically or cytologically confirmed patients with advanced malignant tumors who fail to receive standard treatment or have no standard treatment or are not suitable for standard treatment at this stage
The estimated survival time is more than 3 months
At least one assessable tumor lesion (solid tumors according to RECIST 1.1, lymphoma according to Lugano 2014)
ECOG physical strength score 0-1
Enough organ function
Blood routine (no blood transfusion or colony stimulating factor (G-CSF)
treatment within 14 days):ANC1.5109 / L, PLT75109 / L, Hb80g/L;Liver function
TBIL1.5ULN, ALT2.5ULN, AST2.5ULN (ALT=5ULN for liver metastasis patients
AST5ULN);Renal function: Cr 1.5 ULN, and creatinine clearance > 50 ml
(according to Croft - Gault formula) Coagulation function: activated partial
thromboplastin time (APTT) 1.5 times ULN, prothrombin time (PT) 1.5 times ULN
international normalized ratio (INR) 1.5 times 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; female patients of
childbearing age are selected before the election. The blood or urine
pregnancy test within the day must be negative
\. Prior to the trial, the subject shall have informed consent to the study
and voluntarily sign a written form of informed consent

Exclusion Criteria

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 at least 6 weeks from the last administration, oral fluorouracil drugs such as tegiol and capecitabine are at least 2 weeks from the last administration, and small molecule targeted drugs are at the last administration). At least 2 weeks, or at least 5 half-lives, whichever is longer
Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first administration
Adverse reactions of antineoplastic therapy in the past have not been restored to CTCAE grade 5.01 (except for hair loss and other adverse reactions that the investigator judges have no safety risk)
Brain metastasis, spinal cord compression, cancerous meningitis with clinical symptoms, or other evidence that the metastasis of brain and spinal cord has not yet been controlled, are not suitable for the group judged by the researchers; patients with suspected clinical symptoms of brain or pia mater diseases need to be excluded by CT/MRI examination
Those who have previously received treatment with PD-1 or PD-L1 inhibitors
In the past, immune-related adverse events (> grade 3) have occurred in immunotherapy (irAE, see Appendix 5)
Patients with active or recurrent autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.)
Current or previous patients with interstitial lung disease
Uncontrolled active infections
History of immunodeficiency, including positive HIV antibody test
Patients with active hepatitis B (HBV titer higher than detection limit) ; hepatitis C virus infection
Those with a history of serious cardiovascular disease
Patients with other serious systemic disease history who are judged to be unsuitable for clinical trials
Alcohol or drug dependence is known
Mental disorder or poor compliance
Pregnant or lactating women
Acceptance of live attenuated vaccine within 4 weeks before the first administration or during the study period is planned
Researchers believe that there are any abnormal clinical or laboratory examinations or other reasons in the subjects and that they are not suitable for this clinical study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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