LZM009 to Treat Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03286296|
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Biological: LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation Study of LZM009 in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||August 21, 2017|
|Actual Primary Completion Date :||March 6, 2019|
|Actual Study Completion Date :||April 23, 2019|
Biological: LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection
LZM009 doses of 1, 3, and 10 mg/kg will be administrated intravenously on day 1 and 29 and every 3 weeks thereafter until disease progression or intolerable toxicity, withdrawal of consent, or end of study
- Determine number of patients experiencing dose limiting toxicities [ Time Frame: Day 1 through Day 28 ]And frequency and severity of DLT at LZM009 doses of 1mg/kg, 3mkg/kg and 10mkg/kg at 28 days after the first dose.
- Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: 17 months ]Determination of MTD and RP2D is dependent on number of cohorts and patients experiencing DLT.
- Number of patients experiencing clinical or laboratory adverse events as a measure of safety and tolerability [ Time Frame: Screening to 28 days after last treatment administration, or until drug related toxicities have resolved, whichever is later; or earlier than 28 days should the patient commence another anti-cancer therapy in the meantime, approximately 17 weeks. ]Safety variables include incidence and severity of treatment emergent adverse events (TEAEs) and immune-related AEs (irAEs), vital signs measurements, clinical laboratory values and ECGs as determined by CTCAEv4.03.
- Characterize the pharmacokinetics (PK) profiles of LZM009 in blood specimens of subjects with at least 1 dose [ Time Frame: Predose, 0 h, 2 h, 6h, 24h, days 3, 8, 15 and 22 post infusion of cycle 1; predose of cycle 2 and 3; pre-dose, 0 h, 2 h, 6h, days 8, and 15 post infusion of cycle 4 and predose of every other cycle after Cycle 5(one cycle=21 days except Cycle 1=28 days). ]
- Characterize the immunogenicity profiles of LZM009 in blood specimens of subjects with at least 1 dose [ Time Frame: Predose on C1D1, C2D1, C4D1, and at predose of every other cycle after Cycle 5, thereafter for the first 12 months, and 28 days after the last dose(one cycle=21 days except Cycle 1=28 days). ]Presence of anti-LZM009 antibodies/neutralizing anti-LZM009 antibodies (nAbs) and effect on PK of LZM009.
- Assess preliminary anti-tumor activity of LZM009 in subjects with advanced solid tumors [ Time Frame: 17 months ]Overall response rate (ORR) by the Response Criteria in Solid Tumors (RECIST) v1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286296
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49546|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|