Advanced Solid TumoursPhase 1/2NCT06868199
A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
A Phase 1/2 study testing LM-168 and Toripalimab in people with Advanced Solid Tumours, run by LaNova Medicines Limited at 6 sites in 2 countries.
Trial summary
For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- LM-168 and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 6 May 2025to 1 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged ≥18 years old (including boundary values) , male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- 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.
- In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.
Show all 10Show fewer
- Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.
- At least one measurable disease.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
- Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Who cannot join
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.
- 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.
- Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Subjects with uncontrolled tumour-related pain.
- Subjects with known central nervous system (CNS) or meningeal metastasis.
Show all 28Show fewer
- Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.
- Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.
- Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.
- Patients with a history of active or previously confirmed inflammatory bowel disease.
- Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
- 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.
- 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.
- Subjects with the known history of autoimmune disease.
- 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.
- Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-168.
- Current or recent use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
- Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for > 2 weeks prior to the first dose of LM-168.
- Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).
- Subjects who have severe cardiovascular disease.
- Subjects who have uncontrolled or severe illness.
- Subjects who have a history of immunodeficiency disease.
- HIV infection, active infection including tuberculosis, HBV and HCV infection.
- Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.
- Child-bearing potential female who have positive results in pregnancy test or are lactating.
- Subjects who have psychiatric illness or disorders that may preclude study compliance.
- Subject who is judged as not eligible to participate in this study by the investigator.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia5 sites, 5 recruiting
- Recruiting
Bayview Health-Investigational Drug Services
Perth, Western Australia, 6009
Muhammad Usman Hakeem, Dr, 0862799466, usman.hakeem@oneclinicalresearch.com.au
- Recruiting
One Clinical Reasearch
Perth, Western Australia, 6009
Muhammad Usman Hakeem, Dr, 0862799466, usman.hakeem@oneclinicalresearch.com.au
- Recruiting
Macquarie University
Ryde, New South Wales, 2109
Andrew Parsonson, Dr, 0298122956, andrew.parsonson@mqhealth.org.au
- Recruiting
MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy
Ryde, New South Wales, 2109
Andrew Parsonson, Dr, 0298122956, andrew.parsonson@mqhealth.org.au
- Recruiting
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales
Udit Nindra, Dr, UNindra@cancercarewollongong.com.au
China1 site, 1 recruiting
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Lin Shen, Dr, 13564682439, paulkong@lanovamed.com
About this study
Official 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
For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.
For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.
- Conditions
- Advanced Solid Tumours
- Being tested
- LM-168, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-168Drug
Q3W,Intravenous Drip
ToripalimabDrug
Q3W,Intravenous
| Study group | Role | What they receive |
|---|---|---|
| LM-168 Dose Escalation | Experimental | Not described Receives: Drug: LM-168 |
| LM-168 Dose Expansion | Experimental | Not described Receives: Drug: LM-168 |
| LM-168 combination dose escalation | Experimental | Not described Receives: Drug: LM-168; Drug: Toripalimab |
| LM-168 combination dose expansion | Experimental | Not described Receives: Drug: LM-168; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Phase I
Measured: 78 weeks
Incidence of dose-limitingtoxicity (DLT)
Phase I
Measured: 78 weeks
Incidence of serious adverse event (SAE)
Phase I
Measured: 78 weeks
Temperature (Celsius)
Phase I
Measured: 78 weeks
Pulse in BPM(Beat per Minute)
Phase I
Measured: 78 weeks
Blood Pressure in mmHg
Phase I
Measured: 78 weeks
Weight in Kg
Phase I
Measured: 78 weeks
Height in centimeter
Phase I
Measured: 78 weeks
Blood Routine examination
Phase I
Measured: 78 weeks
Urine Routine test
Phase I
Measured: 78 weeks
Blood biochemistry test
Phase I
Measured: 78 weeks
Coangulation function test
Phase I
Measured: 78 weeks
Thyroid function test
Phase I
Measured: 78 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in HR
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in RR
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in PR
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in QRS
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in QT
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase I
Measured: 78 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase I
Measured: 78 weeks
Objective Response Rate (ORR)
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Secondary outcomes (28)
Objective Response Rate (ORR)
Phase I
Measured: 78 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase I/II
Measured: 130 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase I/II
Measured: 130 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase I/II
Measured: 130 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase I/II
Measured: 130 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase I/II
Measured: 130 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase I/II
Measured: 130 weeks
PK Parameter: Accumulation Ratio (Rac)
Phase I/II
Measured: 130 weeks
PK Parameter: Elimination Half-life (t1/2)
Phase I/II
Measured: 130 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase I/II
Measured: 130 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase I/II
Measured: 130 weeks
Immunogenicity testing
Phase I/II
Measured: 130 weeks
Duration of Response (DOR) in Month
Phase I/II
Measured: 130 weeks
Disease control rate (DCR) in percentage
Phase I/II
Measured: 130 weeks
progression-free survival (PFS) in Month
Phase I/II
Measured: 130 weeks
Changes of target lesions from baseline in Millimeter
Phase I/II
Measured: 130 weeks
Temperature (Celsius)
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Pulse in BPM(Beat per Minute)
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Blood Pressure in mmHg
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Weight in Kg
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Height in centimeter
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Blood Routine examination
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Urine Routine test
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Blood biochemistry test
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Coangulation function test
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Thyroid function test
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
ECOG(Eastern Cooperative Oncology Group) score
Phase II
Measured: From 78th week to 130th week (52 weeks in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start6 May 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- More trials run by LaNova Medicines LimitedThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherry Qin, Study director, LaNova Medicines Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868199
- Sponsor's protocol ID
- LM168-01-101
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06868199
- Acronym / sponsor ID
- LM168-01-101
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 10 Mar 2025 (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.
For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.
For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LM-168 Dose Escalation | Experimental | Drug: LM-168 |
| LM-168 Dose Expansion | Experimental | Drug: LM-168 |
| LM-168 combination dose escalation | Experimental | Drug: LM-168, Drug: Toripalimab |
| LM-168 combination dose expansion | Experimental | Drug: LM-168, Drug: Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged ≥18 years old (including boundary values) , male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- 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.
Key exclusion criteria (28 listed)
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.
- 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.
- Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Subjects with uncontrolled tumour-related pain.
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 |
|---|---|---|
| LM-168Q3W,Intravenous Drip | Drug | LM-168 Dose Escalation, LM-168 Dose Expansion, LM-168 combination dose escalation, LM-168 combination dose expansion |
| ToripalimabQ3W,Intravenous | Drug | LM-168 combination dose escalation, LM-168 combination dose expansion |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 78 weeks
Phase I
Incidence of dose-limitingtoxicity (DLT)
Time frame: 78 weeks
Phase I
Incidence of serious adverse event (SAE)
Time frame: 78 weeks
Phase I
Temperature (Celsius)
Time frame: 78 weeks
Phase I
Pulse in BPM(Beat per Minute)
Time frame: 78 weeks
Phase I
Blood Pressure in mmHg
Time frame: 78 weeks
Phase I
Weight in Kg
Time frame: 78 weeks
Phase I
Height in centimeter
Time frame: 78 weeks
Phase I
Blood Routine examination
Time frame: 78 weeks
Phase I
Urine Routine test
Time frame: 78 weeks
Phase I
Blood biochemistry test
Time frame: 78 weeks
Phase I
Coangulation function test
Time frame: 78 weeks
Phase I
Thyroid function test
Time frame: 78 weeks
Phase I
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in HR
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in RR
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in PR
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QRS
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QT
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QTcF
Time frame: 78 weeks
Phase I
ECOG(Eastern Cooperative Oncology Group) score
Time frame: 78 weeks
Phase I
Objective Response Rate (ORR)
Time frame: From 78th week to 130th week (52 weeks in total)
Phase II
28 secondary outcomes
Objective Response Rate (ORR)
Time frame: 78 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Time frame: 130 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Time frame: 130 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Time frame: 130 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Time frame: 130 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Time frame: 130 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 130 weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 130 weeks
PK Parameter: Elimination Half-life (t1/2)
Time frame: 130 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 130 weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 130 weeks
Immunogenicity testing
Time frame: 130 weeks
Duration of Response (DOR) in Month
Time frame: 130 weeks
Disease control rate (DCR) in percentage
Time frame: 130 weeks
progression-free survival (PFS) in Month
Time frame: 130 weeks
Changes of target lesions from baseline in Millimeter
Time frame: 130 weeks
Temperature (Celsius)
Time frame: From 78th week to 130th week (52 weeks in total)
Pulse in BPM(Beat per Minute)
Time frame: From 78th week to 130th week (52 weeks in total)
Blood Pressure in mmHg
Time frame: From 78th week to 130th week (52 weeks in total)
Weight in Kg
Time frame: From 78th week to 130th week (52 weeks in total)
Height in centimeter
Time frame: From 78th week to 130th week (52 weeks in total)
Blood Routine examination
Time frame: From 78th week to 130th week (52 weeks in total)
Urine Routine test
Time frame: From 78th week to 130th week (52 weeks in total)
Blood biochemistry test
Time frame: From 78th week to 130th week (52 weeks in total)
Coangulation function test
Time frame: From 78th week to 130th week (52 weeks in total)
Thyroid function test
Time frame: From 78th week to 130th week (52 weeks in total)
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: From 78th week to 130th week (52 weeks in total)
ECOG(Eastern Cooperative Oncology Group) score
Time frame: From 78th week to 130th week (52 weeks in total)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Sherry Qin study director
LaNova Medicines Limited
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LM-168 and Toripalimab in people with Advanced Solid Tumours, run by LaNova Medicines Limited at 6 sites in 2 countries.
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 10 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Yuan (+8615901815211, alexyuan@lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: 78 weeks). The study lists 22 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 12 Sep 2025.