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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05199753




Registration number
NCT05199753
Ethics application status
Date submitted
15/12/2021
Date registered
20/01/2022

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
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
Secondary ID [1] 0 0
LM108-01-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
126 weeks
Primary outcome [2] 0 0
Incidence of dose-limiting toxicity (DLT)
Timepoint [2] 0 0
126 weeks
Primary outcome [3] 0 0
Incidence of serious adverse event (SAE)
Timepoint [3] 0 0
126 weeks
Primary outcome [4] 0 0
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Timepoint [4] 0 0
126 weeks
Secondary outcome [1] 0 0
Incidence of anti-drug antibodies to LM-108
Timepoint [1] 0 0
126 weeks
Secondary outcome [2] 0 0
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Timepoint [2] 0 0
126 weeks
Secondary outcome [3] 0 0
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
Timepoint [3] 0 0
126 weeks
Secondary outcome [4] 0 0
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Timepoint [4] 0 0
126 weeks
Secondary outcome [5] 0 0
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Timepoint [5] 0 0
126 weeks
Secondary outcome [6] 0 0
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Timepoint [6] 0 0
126 weeks
Secondary outcome [7] 0 0
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Timepoint [7] 0 0
126 weeks
Secondary outcome [8] 0 0
PK Parameter: Systemic Clearance at Steady State (CLss)
Timepoint [8] 0 0
126 weeks
Secondary outcome [9] 0 0
PK Parameter: Accumulation Ratio (Rac)
Timepoint [9] 0 0
126 weeks
Secondary outcome [10] 0 0
PK Parameter: Elimination Half-life (t 1/2)
Timepoint [10] 0 0
126 weeks
Secondary outcome [11] 0 0
PK Parameter: Volume of Distribution at Steady-State (Vss)
Timepoint [11] 0 0
126 weeks
Secondary outcome [12] 0 0
PK Parameter: Degree of Fluctuation (DF)
Timepoint [12] 0 0
126 weeks

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [2] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [3] 0 0
ICON Cancer Centre - South Brisbane
Recruitment hospital [4] 0 0
Cabrini Health Limited - Malvern
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
One Clinical Research Pty Ltd. - Nedlands
Recruitment postcode(s) [1] 0 0
NSW 2148 - Sydney
Recruitment postcode(s) [2] 0 0
QLD 4575 - Birtinya
Recruitment postcode(s) [3] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
VIC 3144 - Malvern
Recruitment postcode(s) [5] 0 0
VIC 3004 - Melbourne
Recruitment postcode(s) [6] 0 0
WA 6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LaNova Australia Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
LaNova PM
Address 0 0
Country 0 0
Phone 0 0
+8615901815211
Fax 0 0
Email 0 0
alexyuan@lanovamed.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05199753