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Not yet recruiting NCT07694765

A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Malignant Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LM-364 for injection, Tislelizumab.
Who it may be relevant to
Registry conditions: Malignant Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

Overview

For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors. For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.

Interventions

  • Drug LM-364 for injection
    Q3W, Intravenous Drip
  • Drug Tislelizumab
    Q3W, Intravenous Drip

Primary outcome measures

  • Incidence of dose-limiting toxicity (DLT) [Time frame: 78 weeks]
  • Incidence of Treatment-Emergent Adverse Events (AEs) [Time frame: 78 weeks]
  • Incidence of serious adverse events (SAEs) [Time frame: 78 weeks]
  • Temperature (Celsius) [Time frame: 78 weeks]
  • Pulse in BPM(Beat per Minute) [Time frame: 78 weeks]
  • Blood Pressure in mmHg [Time frame: 78 weeks]
  • Weight in Kg [Time frame: 78 weeks]
  • Height in centimeters [Time frame: 78 weeks]
  • Blood Routine examination -> Complete Blood Count [Time frame: 78 weeks]
  • Urine Routine examination ->Urinalysis [Time frame: 78 weeks]
Secondary outcome measures (12)
  • Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) [Time frame: 130 weeks]
  • PK Parameter:Time of Maximum Observed Concentration (Tmax) [Time frame: 130 weeks]
  • PK Parameter: Area Under the Concentration-time Curve (AUC) [Time frame: 130 weeks]
  • PK Parameter: Steady State Maximum Concentration (Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss) [Time frame: 130 weeks]
  • PK Parameter: Steady State Minimum Concentration (Cmin,ss) [Time frame: 130 weeks]
  • PK Parameter: Systemic Clearance at Steady State (CLss) [Time frame: 130 weeks]
  • PK Parameter: Accumulation Ratio (Rac) [Time frame: 130 weeks]
  • PK Parameter: Elimination Half-life (t1/2) [Time frame: 130 weeks]
  • PK Parameter: Volume of Distribution at Steady-State (Vss) [Time frame: 130 weeks]
  • PK Parameter: Degree of Fluctuation (DF) [Time frame: 130 weeks]
  • Immunogenicity testing->Anti-Drug Antibody test [Time frame: 130 weeks]
  • Objective Response Rate (ORR) [Time frame: 130 weeks]

Eligibility criteria

Inclusion criteria

  • Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥ 3 months.
  • Adequate organ and bone marrow function as defined by protocol.
  • Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion criteria

  • Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
  • Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
  • Participants with uncontrolled tumour-related pain.
  • Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
  • Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
  • Participants who have severe cardiovascular disease.
  • Participants who have uncontrolled or severe illness.
  • Participants who have a history of immunodeficiency disease.
  • Participants with a known history of autoimmune disease.
  • Participants who have other active malignancies which are likely to require the treatment.
  • Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • Participants who have psychiatric illness or disorders that may preclude study compliance.
  • Participants who is judged as not eligible to participate in this study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • Macquarie University — North Ryde
  • Cancer Care Wollongong Hospital — Wollongong
  • Icon Cancer Centre South Brisbane — Brisbane

Identifiers

NCT: NCT07694765 · LM364-01-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗