Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06868199




Registration number
NCT06868199
Ethics application status
Date submitted
6/02/2025
Date registered
10/03/2025
Date last updated
12/09/2025

Titles & IDs
Public title
A Study of LM-168 as a Single Agent or in Combination With Toripalimab 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-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
Secondary ID [1] 0 0
LM168-01-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LM-168
Treatment: Drugs - Toripalimab

Experimental: LM-168 Dose Escalation -

Experimental: LM-168 Dose Expansion -

Experimental: LM-168 combination dose escalation -

Experimental: LM-168 combination dose expansion -


Treatment: Drugs: LM-168
Q3W,Intravenous Drip

Treatment: Drugs: Toripalimab
Q3W,Intravenous
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
78 weeks
Primary outcome [2] 0 0
Incidence of dose-limitingtoxicity (DLT)
Timepoint [2] 0 0
78 weeks
Primary outcome [3] 0 0
Incidence of serious adverse event (SAE)
Timepoint [3] 0 0
78 weeks
Primary outcome [4] 0 0
Temperature (Celsius)
Timepoint [4] 0 0
78 weeks
Primary outcome [5] 0 0
Pulse in BPM(Beat per Minute)
Timepoint [5] 0 0
78 weeks
Primary outcome [6] 0 0
Blood Pressure in mmHg
Timepoint [6] 0 0
78 weeks
Primary outcome [7] 0 0
Weight in Kg
Timepoint [7] 0 0
78 weeks
Primary outcome [8] 0 0
Height in centimeter
Timepoint [8] 0 0
78 weeks
Primary outcome [9] 0 0
Blood Routine examination
Timepoint [9] 0 0
78 weeks
Primary outcome [10] 0 0
Urine Routine test
Timepoint [10] 0 0
78 weeks
Primary outcome [11] 0 0
Blood biochemistry test
Timepoint [11] 0 0
78 weeks
Primary outcome [12] 0 0
Coangulation function test
Timepoint [12] 0 0
78 weeks
Primary outcome [13] 0 0
Thyroid function test
Timepoint [13] 0 0
78 weeks
Primary outcome [14] 0 0
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Timepoint [14] 0 0
78 weeks
Primary outcome [15] 0 0
12-lead electrocardiogram (ECG) in HR
Timepoint [15] 0 0
78 weeks
Primary outcome [16] 0 0
12-lead electrocardiogram (ECG) in RR
Timepoint [16] 0 0
78 weeks
Primary outcome [17] 0 0
12-lead electrocardiogram (ECG) in PR
Timepoint [17] 0 0
78 weeks
Primary outcome [18] 0 0
12-lead electrocardiogram (ECG) in QRS
Timepoint [18] 0 0
78 weeks
Primary outcome [19] 0 0
12-lead electrocardiogram (ECG) in QT
Timepoint [19] 0 0
78 weeks
Primary outcome [20] 0 0
12-lead electrocardiogram (ECG) in QTcF
Timepoint [20] 0 0
78 weeks
Primary outcome [21] 0 0
ECOG(Eastern Cooperative Oncology Group) score
Timepoint [21] 0 0
78 weeks
Primary outcome [22] 0 0
Objective Response Rate (ORR)
Timepoint [22] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
78 weeks
Secondary outcome [2] 0 0
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Timepoint [2] 0 0
130 weeks
Secondary outcome [3] 0 0
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Timepoint [3] 0 0
130 weeks
Secondary outcome [4] 0 0
PK Parameter: Area Under the Concentration-time Curve(AUC)
Timepoint [4] 0 0
130 weeks
Secondary outcome [5] 0 0
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Timepoint [5] 0 0
130 weeks
Secondary outcome [6] 0 0
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Timepoint [6] 0 0
130 weeks
Secondary outcome [7] 0 0
PK Parameter: Systemic Clearance at Steady State (CLss)
Timepoint [7] 0 0
130 weeks
Secondary outcome [8] 0 0
PK Parameter: Accumulation Ratio (Rac)
Timepoint [8] 0 0
130 weeks
Secondary outcome [9] 0 0
PK Parameter: Elimination Half-life (t1/2)
Timepoint [9] 0 0
130 weeks
Secondary outcome [10] 0 0
PK Parameter: Volume of Distribution at Steady-State (Vss)
Timepoint [10] 0 0
130 weeks
Secondary outcome [11] 0 0
PK Parameter: Degree of Fluctuation (DF)
Timepoint [11] 0 0
130 weeks
Secondary outcome [12] 0 0
Immunogenicity testing
Timepoint [12] 0 0
130 weeks
Secondary outcome [13] 0 0
Duration of Response (DOR) in Month
Timepoint [13] 0 0
130 weeks
Secondary outcome [14] 0 0
Disease control rate (DCR) in percentage
Timepoint [14] 0 0
130 weeks
Secondary outcome [15] 0 0
progression-free survival (PFS) in Month
Timepoint [15] 0 0
130 weeks
Secondary outcome [16] 0 0
Changes of target lesions from baseline in Millimeter
Timepoint [16] 0 0
130 weeks
Secondary outcome [17] 0 0
Temperature (Celsius)
Timepoint [17] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [18] 0 0
Pulse in BPM(Beat per Minute)
Timepoint [18] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [19] 0 0
Blood Pressure in mmHg
Timepoint [19] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [20] 0 0
Weight in Kg
Timepoint [20] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [21] 0 0
Height in centimeter
Timepoint [21] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [22] 0 0
Blood Routine examination
Timepoint [22] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [23] 0 0
Urine Routine test
Timepoint [23] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [24] 0 0
Blood biochemistry test
Timepoint [24] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [25] 0 0
Coangulation function test
Timepoint [25] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [26] 0 0
Thyroid function test
Timepoint [26] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [27] 0 0
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Timepoint [27] 0 0
From 78th week to 130th week (52 weeks in total)
Secondary outcome [28] 0 0
ECOG(Eastern Cooperative Oncology Group) score
Timepoint [28] 0 0
From 78th week to 130th week (52 weeks in total)

Eligibility
Key inclusion criteria
1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Aged =18 years old (including boundary values) , male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Life expectancy = 3 months.
5. In dose escalation stage, subjects must have 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.
6. In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.
7. Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.
8. At least one measurable disease.
9. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.
2. Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
3. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
4. Any adverse event from prior anti-tumour therapy has not yet recovered to = grade 1 of CTCAE v5.0.
5. Subjects with uncontrolled tumour-related pain.
6. Subjects with known central nervous system (CNS) or meningeal metastasis.
7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
8. Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.
9. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.
10. Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.
11. Patients with a history of active or previously confirmed inflammatory bowel disease.
12. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
13. Subjects who previously experienced grade = 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.
14. Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-168.
15. Subjects with the known history of autoimmune disease.
16. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis or evidence of active pneumonitis on screening chest CT scan.
17. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-168.
18. Current or recent use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
19. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for > 2 weeks prior to the first dose of LM-168.
20. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).
21. Subjects who have severe cardiovascular disease.
22. Subjects who have uncontrolled or severe illness.
23. Subjects who have a history of immunodeficiency disease.
24. HIV infection, active infection including tuberculosis, HBV and HCV infection.
25. Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.
26. Child-bearing potential female who have positive results in pregnancy test or are lactating.
27. Subjects who have psychiatric illness or disorders that may preclude study compliance.
28. Subject who is judged as not eligible to participate in this study by the investigator.

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
6/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
87
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Macquarie University - Ryde
Recruitment hospital [2] 0 0
MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy - Ryde
Recruitment hospital [3] 0 0
Cancer Care Wollongong Pty Limited - Wollongong
Recruitment hospital [4] 0 0
Bayview Health-Investigational Drug Services - Perth
Recruitment hospital [5] 0 0
One Clinical Reasearch - Perth
Recruitment postcode(s) [1] 0 0
2109 - Ryde
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing Municipality

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LaNova Medicines 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
Sherry Qin
Address 0 0
LaNova Medicines Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alex Yuan
Address 0 0
Country 0 0
Phone 0 0
+8615901815211
Fax 0 0
Email 0 0
[email protected]
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/NCT06868199