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Active, not recruitingNCT05518045Updated Sep 3, 2026

A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors

A Phase 1/2 interventional study of LM-108 and Toripalimab in Advanced Solid Tumor, sponsored by LaNova Medicines Limited. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by LaNova Medicines Limited · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
392
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

LaNova Medicines Limited is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  3. Subjects with uncontrolled tumor-related pain.
  4. Subjects with known brain metastases.
  5. Uncontrollable clinical third luminal effusion.
  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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
392 participants (estimated)

Study arms

  • Experimental
    LM-108 Dose Escalation

    Drug: LM-108

  • Experimental
    LM-108 Dose Expansion

    Drug: LM-108

  • Experimental
    LM-108 combination dose expansion

    Drug: LM-108 · Drug: Toripalimab

Interventions

  • DrugLM-108

    Administered intravenously

  • DrugToripalimab

    Administered intravenously

06

What researchers measure

Primary outcomes

  1. Phase I Dose Escalation:Incidence of adverse events (AEs)

    Time frame: 152 Weeks

  2. Phase I Dose Escalation:Incidence of dose-limiting toxicity (DLT)

    Time frame: 152 Weeks

  3. Phase I Dose Escalation:Incidence of serious adverse event (SAE)

    Time frame: 152 Weeks

  4. 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

  5. Phase II Dose Expansion Cohort:Objective Response Rate (ORR) Evaluated by Researchers Based on RECIST v1.1

    Time frame: 152 Weeks

Secondary outcomes

  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108

    Time frame: 152 Weeks

  2. PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108

    Time frame: 152 Weeks

  3. PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108

    Time frame: 152 Weeks

  4. PK Parameter: Steady State Maximum Concentration (Cmax,ss)

    Time frame: 152 Weeks

  5. PK Parameter: Steady State Minimum Concentration (Cmin, ss)

    Time frame: 152 Weeks

  6. PK Parameter: Systemic Clearance at Steady State (CLss)

    Time frame: 152 Weeks

  7. PK Parameter: Accumulation Ratio (Rac)

    Time frame: 152 Weeks

  8. PK Parameter: Elimination Half-life (t 1/2)

    Time frame: 152 Weeks

  9. PK Parameter: Volume of Distribution at Steady-State (Vss)

    Time frame: 152 Weeks

  10. PK Parameter: Degree of Fluctuation (DF)

    Time frame: 152 Weeks

  11. Incidence of anti-drug antibodies to LM-108

    Time frame: 152 Weeks

  12. 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

  13. 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

  14. 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

  15. 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

  16. Phase II Dose Expansion Cohort:Incidence of adverse events (AEs)

    Time frame: 152 Weeks

  17. Phase II Dose Expansion Cohort:Incidence of serious adverse event (SAE)

    Time frame: 152 Weeks

  18. 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

  19. 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

07

Study locations

1 site
  • Beijing Cancer Hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05518045
Lead sponsor
LaNova Medicines Limited
Responsible party
Sponsor
First posted
Aug 26, 2022
Start date
Aug 26, 2022
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Sep 3, 2026

Study contacts

Lin Shen
principal investigator · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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