A Study of LM-350 in Subjects With Advanced Solid Tumours

NCT07112222 | Recruiting Phase 1

• 1 other identifier: LM350-01-101
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 4

Brief Summary

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-350 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explore the relationship between the biomarkers and the anti-tumor activity of LM-350. For Phase II Dose Expansion Stage, to assess the preliminary anti-tumor activity of LM-350 in patients with advanced solid tumors.

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (21)

• Incidence of dose-limitingtoxicity (DLT)

  Phase I

  78 weeks

• Incidence of Treatment-Emergent Adverse Events (AEs)

  Phase I

  78 weeks

• Incidence of serious adverse events (SAEs)

  Phase I

  78 weeks

• Temperature (Celsius)

  Phase I

  78 weeks

• Pulse in BPM(Beat per Minute)

  Phase I

  78 weeks

• Blood Pressure in mmHg

  Phase I

  78 weeks

• Weight in Kg

  Phase I

  78 weeks

• Height in centimeter

  Phase I

  78 weeks

• Blood Routine examination -> Complete Blood Count

  Phase I

  78 weeks

• Urine Routine examination ->Urinalysis

  Phase I

  78 weeks

• Blood Biochemistry test -> Electrolytes and Metabolic Parameters

  Phase I

  78 weeks

• Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized

  Phase I

  78 weeks

• Pregnancy test

  Phase I

  78 weeks

• Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in HR

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in RR

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in QRS

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in QT

  Phase I

  78 weeks

• 12-lead electrocardiogram (ECG) in QTcF

  Phase I

  78 weeks

• ECOG(Eastern Cooperative Oncology Group) score

  Phase I

  78 weeks

• Objective Response Rate (ORR)

  Phase II

  130 weeks

Secondary Outcomes (38)

• Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

  130 weeks

• PK Parameter:Time of Maximum Observed Concentration (Tmax)

  130 weeks

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

  130 weeks

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

  130 weeks

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

  130 weeks

Study Arms (1)

Phase I Dose Escalation Part and Dose Confirmation Part

EXPERIMENTAL

Drug: LM-350 for injection

Interventions

LM-350 for injection DRUG

Q3W,Intravenous Drip

Phase I Dose Escalation Part and Dose Confirmation Part

Eligibility Criteria

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

You may qualify if:

• Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Participant 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.
• Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
• Pre-treatment archived tumour tissue (within 3 years) or on-treatment tumour biopsy could be provided for biomarker analysis.
• Must have at least one measurable lesion according to RECIST v1.1.
• Adequate organ and bone marrow function as defined by protocol.
• Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

You may not qualify if:

• Participate in any other clinical trial within 28 days prior to 1st dosing of LM-350.
• Subjects who have received treatment with the same targeting.
• History of ≥ Grade 3 late diarrhea during or after previous treatment with a topoisomerase inhibitor.
• Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.
• Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• Subjects with uncontrolled tumour-related pain.
• Subjects with known central nervous system (CNS) or meningeal metastasis.
• Subjects who have clinically uncontrollable third-space fluid accumulation.
• Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
• Subjects who take systemic corticosteroids (≥ 10 mg/day of prednisone or equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dose of LM-350.
• Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, and any autoimmune, or prior pneumonectomy.
• Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-350.
• Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \> 2 weeks prior to the first dose of LM-350.
• Subjects with active or a documented history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (4)

Cancer Care Wollongong Pty Limited

Wollongong, New South Wales, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, Australia

RECRUITING

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Alex Yuan

CONTACT

+8615901815211; alexyuan@lanovamed.com

Study Design

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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 8, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CN (1)