Solid TumorPhase 1NCT03286296
LZM009 to Treat Patients With Advanced Solid Tumors
A Phase 1 study testing LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection in people with Solid Tumor, run by Livzon Pharmaceutical Group Inc. at 2 sites in United States.
Trial summary
To assess the safety and tolerability of IV administered LZM009 in subjects with advanced solid tumors who have progressed or are non-responsive to available therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2017to 23 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Histologically or cytologically confirmed solid malignancy.
- Male or non-pregnant, non-lactating female patients age ≥18 years.
- Locally advanced or metastatic disease that is refractory to standard therapy [note for patients with NSCLC patients with activating ALK translocation or EGFR mutations must have been treated and failed appropriate therapy], or for which there is no standard available therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Subject with a life expectancy of ≥ 12 weeks.
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- Adequate hematologic function as indicated by
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0g/dL
- Absolute neutrophil count (ANC) ≥1000/uL Note: Use of growth-factors to maintain ANC criterion (within 28 days prior to the first dose of study drug and within 28 days after day 1 of Cycle 1) is not permitted.
- Adequate renal and liver function as indicated by:
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN); if serum creatinine is >1.5 x ULN, creatinine clearance must be ≥ 50 mL/min either by calculation or by measured 24-hour urine collection
- Total bilirubin ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤3 x ULN of institution's normal range; for patients with known liver metastases, AST and ALT may be ≤ 5 x ULN.
- Coagulation: aPTT and PT≤ 1.3 x ULN
- Patients with brain metastases are eligible if clinically controlled that is defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function \& no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
- Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.
- Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
- Willingness and ability to comply with study procedures and follow-up examination.
Who cannot join
- To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- Receiving concurrent anti-cancer therapy or investigational therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, (with the exception of hormones for hypothyroidism, estrogen replacement therapy, or LHRH agonists required to suppress serum testosterone levels).
- Patients who have experienced a Grade 3 or higher toxicity related to prior PD-1/PD-L1 treatment.
- Prior anticancer therapy less than 21 days of study entry, or 5 half-lives, whichever is shorter.
- Steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of study drug.
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1.
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- Known bleeding diathesis/disorder unless controlled.
- Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
- Have active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
- Serious gastrointestinal bleeding within 3 months.
- Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug and within 28 days after the first dose.
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the planned first dose of study drug. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Ophthalmologic, nasal and intra-articular injections or steroids are acceptable.
- Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
- Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
- Neurologic instability per clinical evaluation due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for>28 days may be enrolled.
- Positive laboratory test for HBsAg or anti-HCV. Patients with anti-hepatitis B core antibody are eligible if negative for HBsAg; patients positive for anti-HCV may be enrolled if negative by nucleic acid amplification test.
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
- Any diagnosis of autoimmune disease. Subjects with hypothyroidism stable on hormone replacement, adrenal insufficiency on steroid replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment are permitted to enroll.
- Grade 3 or higher pneumonitis or neuropathy during previous treatment with immunotherapy.
- Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
- Uncontrolled concurrent illness including, but not limited to: serious uncontrolled diabetes (blood glucose > 250 mg/dL), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
- Patient has received a live, attenuated vaccine within 28 days of planned start of study therapy.
- Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia), or to LZM009 recipients (refer to Investigator's Brochure).
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 21 days or 5 half-lives, whichever is shorter, before the start of study treatment, the exception of participants in the follow-up phase.
- Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
START Midwest
Grand Rapids, Michigan, 49546
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation Study of LZM009 in Subjects With Advanced Solid Tumors
To assess the safety and tolerability of IV administered LZM009 in subjects with advanced solid tumors who have progressed or are non-responsive to available therapies.
- Conditions
- Solid Tumor
- Being tested
- LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injectionBiological
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
| Study group | Role | What they receive |
|---|---|---|
| LZM009 | Experimental | Not described Receives: Biological: LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine number of patients experiencing dose limiting toxicities
And frequency and severity of DLT at LZM009 doses of 1mg/kg, 3mkg/kg and 10mkg/kg at 28 days after the first dose.
Measured: Day 1 through Day 28
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Determination of MTD and RP2D is dependent on number of cohorts and patients experiencing DLT.
Measured: 17 months
Number of patients experiencing clinical or laboratory adverse events as a measure of safety and tolerability
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.
Measured: 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.
Secondary outcomes (3)
Characterize the pharmacokinetics (PK) profiles of LZM009 in blood specimens of subjects with at least 1 dose
Measured: 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
Presence of anti-LZM009 antibodies/neutralizing anti-LZM009 antibodies (nAbs) and effect on PK of LZM009.
Measured: 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).
Assess preliminary anti-tumor activity of LZM009 in subjects with advanced solid tumors
Overall response rate (ORR) by the Response Criteria in Solid Tumors (RECIST) v1.1.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start21 Aug 2017
- Primary completion6 Mar 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286296
- Sponsor's protocol ID
- LZM009-001
- Status last verified
- Aug 2019
- First submitted
- 8 Sep 2017
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation Study of LZM009 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03286296
- Acronym / sponsor ID
- LZM009-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and tolerability of IV administered LZM009 in subjects with advanced solid tumors who have progressed or are non-responsive to available therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LZM009 | Experimental | Biological: LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Histologically or cytologically confirmed solid malignancy.
- Male or non-pregnant, non-lactating female patients age ≥18 years.
- Locally advanced or metastatic disease that is refractory to standard therapy [note for patients with NSCLC patients with activating ALK translocation or EGFR mutations must have been treated and failed appropriate therapy], or for which there is no standard available therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Key exclusion criteria (25 listed)
- To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- Receiving concurrent anti-cancer therapy or investigational therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, (with the exception of hormones for hypothyroidism, estrogen replacement therapy, or LHRH agonists required to suppress serum testosterone levels).
- Patients who have experienced a Grade 3 or higher toxicity related to prior PD-1/PD-L1 treatment.
- Prior anticancer therapy less than 21 days of study entry, or 5 half-lives, whichever is shorter.
- Steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injectionLZM009 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 | Biological | LZM009 |
Primary outcome
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.
3 secondary outcomes
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).
Assess preliminary anti-tumor activity of LZM009 in subjects with advanced solid tumors
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection in people with Solid Tumor, run by Livzon Pharmaceutical Group Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine number of patients experiencing dose limiting toxicities (time frame: Day 1 through Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.