Actively Recruiting
A Phase I/II, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LM-350 in Patients with Advanced Solid Tumors
Led by LaNova Medicines Limited · Updated on 2026-01-26
80
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LM-350, an experimental drug, for safety, tolerability, and preliminary anti-tumor activity in patients with advanced solid tumors. The study is a Phase I/II clinical trial designed to find the maximum tolerated or optimal biological dose and explore how biomarkers relate to the drug's anti-tumor effects. This trial is sponsored by LaNova Medicines Limited and includes patients who have failed or cannot tolerate standard treatments. Participants will receive LM-350 by intravenous drip every three weeks during the study. The trial consists of a Phase I dose escalation to determine safe dosage levels, followed by a Phase II dose expansion to assess early anti-tumor activity. Treatment and monitoring continue over extended periods to evaluate the drug's effects and safety. During the study, participants will undergo regular assessments including physical exams, vital signs, blood and urine tests, ECGs, echocardiography, and tumor biomarker analyses. Researchers will track side effects, tumor response, pharmacokinetics, and immune response over up to 130 weeks. Safety monitoring includes checking for adverse events, heart function, and laboratory parameters to ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
A Study of LM-350 in Subjects With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate and sign informed consent before any procedure
- Age 18 years or older at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Advanced solid tumors confirmed by histopathology with failed, intolerant, or unsuitable standard treatment
- Ability to provide pre-treatment archived tumor tissue or on-treatment biopsy for biomarker analysis
- At least one measurable lesion according to RECIST v1.1
- Adequate organ and bone marrow function as defined by protocol
- Ability to communicate well with investigators and comply with study requirements
You will not qualify if you...
- Participation in another clinical trial within 28 days before first LM-350 dose
- Prior treatment targeting the same mechanism as LM-350
- History of Grade 3 or higher late diarrhea after topoisomerase inhibitor treatment
- Recent anti-tumor treatments within specified washout periods
- Unresolved adverse events from prior therapy above Grade 1 CTCAE v5.0
- Uncontrolled tumor-related pain
- Known central nervous system or meningeal metastases
- Clinically uncontrollable third-space fluid accumulation
- Severe hypersensitivity to monoclonal antibody treatments
- Use of systemic corticosteroids or immunosuppressives within 2 weeks before dosing
- History or current interstitial lung disease or pneumonitis requiring steroids
- Severe pulmonary compromise, autoimmune disease, or prior pneumonectomy
- Use of live attenuated vaccines within 28 days before dosing
- Unstable use of anticoagulants or thrombolytics within 2 weeks before dosing
- Active or history of chronic inflammatory bowel disease
- Intestinal obstruction or risk of intestinal perforation within 3 months before dosing
- Major surgery or interventional treatment within 28 days before dosing
- Severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency disease
- Active infections including HIV, tuberculosis, HBV, or HCV
- Other active malignancies likely requiring treatment
- Female participants with childbearing potential who test positive for pregnancy or are lactating
- Psychiatric illness or disorders that may affect study compliance
- Investigator judgment deeming participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 78 weeks
Participants receive LM-350 by intravenous drip every 3 weeks as part of the study treatment.
Visits every 3 weeks for treatment administration and assessments
Duration - Up to 52 weeks following treatment
Participants are monitored for safety, efficacy, and other health outcomes after treatment ends.
Regular visits for assessments up to 52 weeks after treatment ends
Trial Site Locations
Total: 4 locations
1
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia
Actively Recruiting
2
Cancer Research SA
Adelaide, South Australia, Australia
Actively Recruiting
3
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Actively Recruiting
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
Research Team
A
Alex Yuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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