Advanced Solid TumorPhase 1/2NCT05518045
A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing LM-108 and Toripalimab in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 1 site in China.
Trial summary
A Phase I/II, Open-Label, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108, an Anti-CCR8 Monoclonal Antibody, as Monotherapy or in Combination with Antitumor Therapies in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LM-108 and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2022to 31 Oct 2026
- 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 to 80 years
- 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
- Have received anti-CCR8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose.
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Subjects with uncontrolled tumor-related pain.
- Subjects with known brain metastases.
- Uncontrollable clinical third luminal effusion.
- Known history of autoimmune disease.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108 for Injection as Monotherapy or in Combination With Antitumor Therapies in Patients With Advanced Solid Tumors
A Phase I/II, Open-Label, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108, an Anti-CCR8 Monoclonal Antibody, as Monotherapy or in Combination with Antitumor Therapies in Patients with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- LM-108, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-108Drug
Administered intravenously
ToripalimabDrug
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 expansion | Experimental | Not described Receives: Drug: LM-108; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Dose Escalation:Incidence of adverse events (AEs)
Measured: 152 Weeks
Phase I Dose Escalation:Incidence of dose-limiting toxicity (DLT)
Measured: 152 Weeks
Phase I Dose Escalation:Incidence of serious adverse event (SAE)
Measured: 152 Weeks
Phase I Dose Escalation:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Objective Response Rate (ORR) Evaluated by Researchers Based on RECIST v1.1
Measured: 152 Weeks
Secondary outcomes (19)
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Measured: 152 Weeks
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Measured: 152 Weeks
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Measured: 152 Weeks
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Measured: 152 Weeks
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Measured: 152 Weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Measured: 152 Weeks
PK Parameter: Accumulation Ratio (Rac)
Measured: 152 Weeks
PK Parameter: Elimination Half-life (t 1/2)
Measured: 152 Weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Measured: 152 Weeks
PK Parameter: Degree of Fluctuation (DF)
Measured: 152 Weeks
Incidence of anti-drug antibodies to LM-108
Measured: 152 Weeks
Phase I Dose Escalation：Preliminary anti-tumor activity：Objective Response Rate,Duration of Response, Disease Control Rate,Progression-Free Survival,and Overall Survival evaluated according to the Response Evaluation Criteria in Solid Tumors (RECISTv1.1)
Measured: 152 Weeks
Phase I Dose Escalation：Correlation between biomarker expression levels (FoxP3, PD-L1, CCR8, CD8) and the anti-tumor activity of LM-108 as monotherapy or in combination with toripalimab.
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Antitumor Activity: Duration of Response (DOR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS) evaluated by investigators based on RECIST v1.1;
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Objective Response Rate (ORR), DOR, DCR, and PFS evaluated by the Independent Review Committee (IRC) based on RECIST v1.1
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Incidence of adverse events (AEs)
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Incidence of serious adverse event (SAE)
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Measured: 152 Weeks
Phase II Dose Expansion Cohort:Correlation between biomarker expression levels (FoxP3, PD-L1, CCR8, CD8) and the anti-tumor activity of LM-108 as monotherapy or in combination with anti-tumor therapies.
Measured: 152 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start26 Aug 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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.
- 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
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518045
- Sponsor's protocol ID
- LM108-01-103
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108 for Injection as Monotherapy or in Combination With Antitumor Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05518045
- Acronym / sponsor ID
- LM108-01-103
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Aug 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.
A Phase I/II, Open-Label, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108, an Anti-CCR8 Monoclonal Antibody, as Monotherapy or in Combination with Antitumor Therapies in Patients with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LM-108 Dose Escalation | Experimental | Drug: LM-108 |
| LM-108 Dose Expansion | Experimental | Drug: LM-108 |
| LM-108 combination dose expansion | Experimental | Drug: LM-108, Drug: Toripalimab |
Who may qualify
- Ages
- 18 to 80 years
- 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 (13 listed)
- Have received anti-CCR8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose.
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Subjects with uncontrolled tumor-related pain.
- Subjects with known brain metastases.
- Uncontrollable clinical third luminal effusion.
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 expansion |
| ToripalimabAdministered intravenously | Drug | LM-108 combination dose expansion |
Primary outcome
Phase I Dose Escalation:Incidence of adverse events (AEs)
Time frame: 152 Weeks
Phase I Dose Escalation:Incidence of dose-limiting toxicity (DLT)
Time frame: 152 Weeks
Phase I Dose Escalation:Incidence of serious adverse event (SAE)
Time frame: 152 Weeks
Phase I Dose Escalation:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Objective Response Rate (ORR) Evaluated by Researchers Based on RECIST v1.1
Time frame: 152 Weeks
19 secondary outcomes
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Time frame: 152 Weeks
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Time frame: 152 Weeks
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Time frame: 152 Weeks
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Time frame: 152 Weeks
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Time frame: 152 Weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 152 Weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 152 Weeks
PK Parameter: Elimination Half-life (t 1/2)
Time frame: 152 Weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 152 Weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 152 Weeks
Incidence of anti-drug antibodies to LM-108
Time frame: 152 Weeks
Phase I Dose Escalation：Preliminary anti-tumor activity：Objective Response Rate,Duration of Response, Disease Control Rate,Progression-Free Survival,and Overall Survival evaluated according to the Response Evaluation Criteria in Solid Tumors (RECISTv1.1)
Time frame: 152 Weeks
Phase I Dose Escalation：Correlation between biomarker expression levels (FoxP3, PD-L1, CCR8, CD8) and the anti-tumor activity of LM-108 as monotherapy or in combination with toripalimab.
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Antitumor Activity: Duration of Response (DOR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS) evaluated by investigators based on RECIST v1.1;
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Objective Response Rate (ORR), DOR, DCR, and PFS evaluated by the Independent Review Committee (IRC) based on RECIST v1.1
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Incidence of adverse events (AEs)
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Incidence of serious adverse event (SAE)
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Time frame: 152 Weeks
Phase II Dose Expansion Cohort:Correlation between biomarker expression levels (FoxP3, PD-L1, CCR8, CD8) and the anti-tumor activity of LM-108 as monotherapy or in combination with anti-tumor therapies.
Time frame: 152 Weeks
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 3 Sep 2026.
- 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.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
1 site 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 Toripalimab in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 1 site in China.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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?
Phase I Dose Escalation:Incidence of adverse events (AEs) (time frame: 152 Weeks). The study lists 5 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 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.