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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05199753
Registration number
NCT05199753
Ethics application status
Date submitted
15/12/2021
Date registered
20/01/2022
Date last updated
21/09/2023
Titles & IDs
Public title
Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
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Scientific title
A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
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Secondary ID [1]
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LM108-01-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LM-108
Treatment: Drugs - An Anti-PD-1 Antibody
Experimental: LM-108 Dose Escalation -
Experimental: LM-108 Dose Expansion -
Experimental: LM-108 combination dose escalation -
Experimental: LM-108 combination dose expansion -
Treatment: Drugs: LM-108
Administered intravenously
Treatment: Drugs: An Anti-PD-1 Antibody
Administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of adverse events (AEs)
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Assessment method [1]
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Timepoint [1]
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126 weeks
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Primary outcome [2]
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Incidence of dose-limiting toxicity (DLT)
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Assessment method [2]
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Timepoint [2]
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126 weeks
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Primary outcome [3]
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Incidence of serious adverse event (SAE)
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Assessment method [3]
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Timepoint [3]
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126 weeks
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Primary outcome [4]
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Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
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Assessment method [4]
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Timepoint [4]
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126 weeks
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Secondary outcome [1]
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Incidence of anti-drug antibodies to LM-108
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Assessment method [1]
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Timepoint [1]
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126 weeks
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Secondary outcome [2]
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Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
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Assessment method [2]
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Timepoint [2]
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126 weeks
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Secondary outcome [3]
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PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
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Assessment method [3]
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Timepoint [3]
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126 weeks
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Secondary outcome [4]
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PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
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Assessment method [4]
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Timepoint [4]
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126 weeks
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Secondary outcome [5]
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PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
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Assessment method [5]
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Timepoint [5]
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126 weeks
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Secondary outcome [6]
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PK Parameter: Steady State Maximum Concentration (Cmax,ss)
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Assessment method [6]
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Timepoint [6]
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126 weeks
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Secondary outcome [7]
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PK Parameter: Steady State Minimum Concentration (Cmin, ss)
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Assessment method [7]
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Timepoint [7]
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126 weeks
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Secondary outcome [8]
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PK Parameter: Systemic Clearance at Steady State (CLss)
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Assessment method [8]
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Timepoint [8]
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126 weeks
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Secondary outcome [9]
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PK Parameter: Accumulation Ratio (Rac)
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Assessment method [9]
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Timepoint [9]
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126 weeks
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Secondary outcome [10]
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PK Parameter: Elimination Half-life (t 1/2)
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Assessment method [10]
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Timepoint [10]
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126 weeks
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Secondary outcome [11]
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PK Parameter: Volume of Distribution at Steady-State (Vss)
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Assessment method [11]
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Timepoint [11]
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126 weeks
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Secondary outcome [12]
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PK Parameter: Degree of Fluctuation (DF)
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Assessment method [12]
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Timepoint [12]
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126 weeks
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Eligibility
Key inclusion criteria
Key
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
2. Histological or cytological confirmation of recurrent or refractory advanced solid
tumours, and have progressed on standard therapy, or are intolerable for available
standard therapy, or there is no available standard therapy.
3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria
in Solid Tumours (RECIST) v1.1.
4. Subjects must show appropriate organ and marrow function in laboratory examinations
within 7 days prior to the first dose
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any adverse event from prior anti-tumour therapy has not yet recovered to =grade 1 of
CTCAE v5.0
2. Uncontrolled tumour-related pain
3. Known central nervous system (CNS)
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures
5. Use of inhaled corticosteroids
6. Known history of autoimmune disease
7. Use of any live attenuated vaccines within 28 days
8. Have severe cardiovascular disease
9. Uncontrolled or severe illness
10. History of immunodeficiency disease
11. Active malignancies which are likely to require the treatment.
12. Child-bearing potential female
13. Have psychiatric illness or disorders
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital - Sydney
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Recruitment hospital [2]
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Sunshine Coast University Private Hospital - Birtinya
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Recruitment hospital [3]
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ICON Cancer Centre - South Brisbane
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Recruitment hospital [4]
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Cabrini Health Limited - Malvern
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Recruitment hospital [5]
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Alfred Hospital - Melbourne
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Recruitment hospital [6]
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One Clinical Research Pty Ltd. - Nedlands
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Recruitment postcode(s) [1]
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NSW 2148 - Sydney
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Recruitment postcode(s) [2]
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QLD 4575 - Birtinya
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Recruitment postcode(s) [3]
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QLD 4101 - South Brisbane
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Recruitment postcode(s) [4]
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VIC 3144 - Malvern
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Recruitment postcode(s) [5]
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VIC 3004 - Melbourne
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Recruitment postcode(s) [6]
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WA 6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
LaNova Australia Pty Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion
study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour
activity of LM-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with
solid tumours.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05199753
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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LaNova PM
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Address
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Country
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Phone
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+8615901815211
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05199753
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