Advanced Solid TumorPhase 1/2NCT05199753
Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
A Phase 1/2 study testing LM-108 and An Anti-PD-1 Antibody in people with Advanced Solid Tumor, run by LaNova Australia Pty Limited at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LM-108 and An Anti-PD-1 Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 6 sitesAustralia
- Study dates
- 16 Mar 2022to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- 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.
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
Who cannot join
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- Uncontrolled tumour-related pain
- Known central nervous system (CNS)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Use of inhaled corticosteroids
- Known history of autoimmune disease
Show all 14Show fewer
- Use of any live attenuated vaccines within 28 days
- Have severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency disease
- Active malignancies which are likely to require the treatment.
- Child-bearing potential female
- Have psychiatric illness or disorders
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Sunshine Coast University Private Hospital
Birtinya, Queensland, QLD 4575
Cabrini Health Limited
Malvern, Victoria, VIC 3144
Alfred Hospital
Melbourne, Victoria, VIC 3004
One Clinical Research Pty Ltd.
Nedlands, Western Australia, WA 6009
ICON Cancer Centre
South Brisbane, Queensland, QLD 4101
Blacktown Hospital
Sydney, New South Wales, NSW 2148
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-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- LM-108, An Anti-PD-1 Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-108Drug
Administered intravenously
An Anti-PD-1 AntibodyDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| LM-108 Dose Escalation | Experimental | Not described Receives: Drug: LM-108 |
| LM-108 Dose Expansion | Experimental | Not described Receives: Drug: LM-108 |
| LM-108 combination dose escalation | Experimental | Not described Receives: Drug: LM-108; Drug: An Anti-PD-1 Antibody |
| LM-108 combination dose expansion | Experimental | Not described Receives: Drug: LM-108; Drug: An Anti-PD-1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: 126 weeks
Incidence of dose-limiting toxicity (DLT)
Measured: 126 weeks
Incidence of serious adverse event (SAE)
Measured: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Measured: 126 weeks
Secondary outcomes (12)
Incidence of anti-drug antibodies to LM-108
Measured: 126 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Measured: 126 weeks
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
Measured: 126 weeks
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Measured: 126 weeks
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Measured: 126 weeks
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Measured: 126 weeks
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Measured: 126 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Measured: 126 weeks
PK Parameter: Accumulation Ratio (Rac)
Measured: 126 weeks
PK Parameter: Elimination Half-life (t 1/2)
Measured: 126 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Measured: 126 weeks
PK Parameter: Degree of Fluctuation (DF)
Measured: 126 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start16 Mar 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- LaNova Australia Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199753
- Sponsor's protocol ID
- LM108-01-101
- Status last verified
- Sep 2025
- First submitted
- 15 Dec 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05199753
- Acronym / sponsor ID
- LM108-01-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- LaNova Australia Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Jan 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LM-108 Dose Escalation | Experimental | Drug: LM-108 |
| LM-108 Dose Expansion | Experimental | Drug: LM-108 |
| LM-108 combination dose escalation | Experimental | Drug: LM-108, Drug: An Anti-PD-1 Antibody |
| LM-108 combination dose expansion | Experimental | Drug: LM-108, Drug: An Anti-PD-1 Antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- 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.
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
Key exclusion criteria (14 listed)
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- Uncontrolled tumour-related pain
- Known central nervous system (CNS)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Use of inhaled corticosteroids
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-108Administered intravenously | Drug | LM-108 Dose Escalation, LM-108 Dose Expansion, LM-108 combination dose escalation, LM-108 combination dose expansion |
| An Anti-PD-1 AntibodyAdministered intravenously | Drug | LM-108 combination dose escalation, LM-108 combination dose expansion |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 126 weeks
Incidence of dose-limiting toxicity (DLT)
Time frame: 126 weeks
Incidence of serious adverse event (SAE)
Time frame: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Time frame: 126 weeks
12 secondary outcomes
Incidence of anti-drug antibodies to LM-108
Time frame: 126 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Time frame: 126 weeks
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
Time frame: 126 weeks
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Time frame: 126 weeks
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Time frame: 126 weeks
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Time frame: 126 weeks
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Time frame: 126 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 126 weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 126 weeks
PK Parameter: Elimination Half-life (t 1/2)
Time frame: 126 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 126 weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 126 weeks
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 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LM-108 and An Anti-PD-1 Antibody in people with Advanced Solid Tumor, run by LaNova Australia Pty Limited at 6 sites in Australia.
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 4 inclusion and 14 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 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. 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?
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?
Incidence of adverse events (AEs) (time frame: 126 weeks). The study lists 4 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.