Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I/II, Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination With Toripalimab in Advanced Solid Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518045
• Other study ID #: LM108-01-103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 26, 2022
• Est. completion date: October 25, 2025

Study information

• Verified date: August 2023
• Source: LaNova Medicines Limited
• Contact: Mengmeng LIU
• Phone: 13918118040
• Email: mengmengliu[@]lanovamed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I/II, open-Label, dose-Escalation and dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 (an Anti-CCR8 mAb) as a Single Agent or in combination with Toripalimab in Advanced Solid Tumours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 392
• Est. completion date: October 25, 2025
• Est. primary completion date: July 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

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. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-108, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.

3. Any adverse event from prior anti-tumor therapy has not yet recovered to = grade 1 of CTCAE v5.0.

4. Subjects with uncontrolled tumor-related pain.

5. Subjects with known brain metastases.

6. Uncontrollable clinical third luminal effusion.

7. Known history of autoimmune disease.

8. Use of any live attenuated vaccines within 28 days.

9. Have severe cardiovascular disease.

10. Uncontrolled or severe illness.

11. History of immunodeficiency disease.

12. Active malignancies which are likely to require the treatment.

13. Child-bearing potential female.

14. Have psychiatric illness or disorders.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• LM-108
Administered intravenously
• Toripalimab
Administered intravenously

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
LaNova Medicines Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		152 Weeks
Primary	Incidence of dose-limiting toxicity (DLT)		152 Weeks
Primary	Incidence of serious adverse event (SAE)		152 Weeks
Primary	Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.		152 Weeks
Secondary	Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108		152 Weeks
Secondary	PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108		152 Weeks
Secondary	PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108		152 Weeks
Secondary	PK Parameter: Steady State Maximum Concentration (Cmax,ss)		152 Weeks
Secondary	PK Parameter: Steady State Minimum Concentration (Cmin, ss)		152 Weeks
Secondary	PK Parameter: Systemic Clearance at Steady State (CLss)		152 Weeks
Secondary	PK Parameter: Accumulation Ratio (Rac)		152 Weeks
Secondary	PK Parameter: Elimination Half-life (t 1/2)		152 Weeks
Secondary	PK Parameter: Volume of Distribution at Steady-State (Vss)		152 Weeks
Secondary	PK Parameter: Degree of Fluctuation (DF)		152 Weeks
Secondary	Incidence of anti-drug antibodies to LM-108		152 Weeks