Clinical Trials/NCT05518045

NCT05518045

Active, not recruiting

Phase 1

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

LaNova Medicines Limited1 site in 1 country392 target enrollmentAugust 26, 2022

ConditionsAdvanced Solid Tumor

InterventionsLM-108 Toripalimab

Overview

Phase: Phase 1
Intervention: LM-108
Conditions: Advanced Solid Tumor
Sponsor: LaNova Medicines Limited
Enrollment: 392
Locations: 1
Primary Endpoint: Phase I Dose Escalation:Incidence of adverse events (AEs)
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 26, 2022

End Date

March 31, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

LaNova Medicines Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•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.
•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.
•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.

Arms & Interventions

LM-108 Dose Escalation

Intervention: LM-108

LM-108 Dose Expansion

Intervention: LM-108

LM-108 combination dose expansion

Intervention: LM-108

LM-108 combination dose expansion

Intervention: Toripalimab

Outcomes

Primary Outcomes

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

Secondary Outcomes

PK Parameter: Accumulation Ratio (Rac)(152 Weeks)
PK Parameter: Elimination Half-life (t 1/2)(152 Weeks)
PK Parameter: Volume of Distribution at Steady-State (Vss)(152 Weeks)
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108(152 Weeks)
PK Parameter: Systemic Clearance at Steady State (CLss)(152 Weeks)
Incidence of anti-drug antibodies to LM-108(152 Weeks)
PK Parameter: Steady State Maximum Concentration (Cmax,ss)(152 Weeks)
PK Parameter: Steady State Minimum Concentration (Cmin, ss)(152 Weeks)
PK Parameter: Degree of Fluctuation (DF)(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)
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)(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.(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;(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(152 Weeks)
Phase II Dose Expansion Cohort:Incidence of adverse events (AEs)(152 Weeks)
Phase II Dose Expansion Cohort:Incidence of serious adverse event (SAE)(152 Weeks)
Phase II Dose Expansion Cohort:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.(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.(152 Weeks)