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

NCT05518045 | Active Not Recruiting Phase 1

• 1 other identifier: LM108-01-103
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (5)

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

  152 Weeks

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

  152 Weeks

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

  152 Weeks

• Phase I Dose Escalation:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.

  152 Weeks

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

  152 Weeks

Secondary Outcomes (19)

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

  152 Weeks

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

  152 Weeks

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

  152 Weeks

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

  152 Weeks

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

  152 Weeks

Study Arms (3)

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

Interventions

LM-108 DRUG

Administered intravenously

LM-108 Dose Escalation; LM-108 Dose Expansion; LM-108 combination dose expansion

Toripalimab DRUG

Administered intravenously

LM-108 combination dose expansion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

MeSH Terms

Interventions

toripalimab

Study Officials

• Lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 26, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)