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【Group News】Lizhu PD-1 Patient Recruitment 1: A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of LZM009 in patients with advanced solid tumors
Published Time：
2018-12-18
1. Trial Drug Introduction
LZM009 is an anti-PD-1 monoclonal antibody developed by Lizhu, and the indication for this trial is advanced solid tumors.
2. Trial Objectives
To evaluate the safety and tolerability of LZM009 in patients with advanced solid tumors, and to provide a basis for determining the recommended Phase II dose (RP2D);
To investigate the pharmacokinetic characteristics (PK parameters) of LZM009 in patients with advanced solid tumors after single and multiple intravenous infusions, and to investigate the generation of anti-LZM009 antibodies (ADA) in patients with advanced solid tumors after single and multiple intravenous infusions.
3. Trial Design
Trial Classification: Other
Trial Phase: Phase I
Design Type: Single-arm trial
Randomization: Non-randomized
Blinding: Open
Trial Scope: Domestic
Number of Subjects: 50-122
4. Inclusion Criteria
1. Age 18-70 years (inclusive), both males and females;
2. ECOG score: 0-1;
3. Histologically or cytologically confirmed advanced solid tumor;
4. According to RECIST 1.1 criteria, subjects must have at least one measurable target lesion that can be assessed by CT or MRI;
5. Expected survival ≥3 months
6. Normal major organ function (within 14 days prior to enrollment), i.e., meeting relevant laboratory test standards;
7. Males with reproductive potential or females with the potential for pregnancy must use highly effective contraception during the trial and continue contraception for 12 months after the last dose;
8. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 hours prior to the first dose; if the urine pregnancy test is positive or cannot be confirmed as negative, further blood pregnancy testing is required;
9. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
5. Exclusion Criteria
1. Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2;
2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
3. Pregnant or lactating women;
4. Positive HIV test result;
5. Patients with active hepatitis B or C;
6. History of definite active tuberculosis;
7. Active autoimmune disease requiring systemic treatment within the past two years; concomitant treatment is allowed;
8. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or progressive (severe) infections, uncontrolled diabetes, cardiovascular disease;
9. Live vaccine administration within 4 weeks prior to treatment initiation;
10. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
11. History of substance abuse that cannot be controlled or history of mental disorders;
12. History of other malignancies within the past 5 years;
13. Other severe, acute, or chronic medical or psychiatric illnesses or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with participation in the study or may interfere with the interpretation of the study results.
6. Investigator Information
|
Name |
Shen Lin, M.D. |
Title |
Chief Physician |
|
Mailing Address |
52 Fucheng Road, Haidian District, Beijing, China |
Zip Code |
1000022 |
|
Institution Name |
Peking University Cancer Hospital |
||
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