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NCT Number: NCT05518045

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

LM-108

Drug

Administered intravenously

Toripalimab

Drug

Administered intravenously

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

Sponsors and collaborators

Lead sponsor

LaNova Medicines Limited

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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