Actively Recruiting
A Study of LM-350 in Subjects With Advanced Solid Tumours
Led by LaNova Medicines Limited · Updated on 2026-01-26
80
Participants Needed
4
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Age 18 years or older at consent
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Advanced solid tumors confirmed by histopathology
- Failed, intolerant, or unsuitable for standard treatment
- Availability of pre-treatment tumor tissue or on-treatment biopsy for biomarker analysis
- At least one measurable lesion per RECIST v1.1
- Adequate organ and bone marrow function
- Ability to communicate and follow study requirements
You will not qualify if you...
- Participation in another clinical trial within 28 days before first LM-350 dose
- Prior treatment with the same targeting agent
- History of Grade 3 or higher late diarrhea with topoisomerase inhibitors
- Recent anti-tumor treatments within specified timeframes
- Unresolved adverse events from prior therapy above Grade 1
- Uncontrolled tumor-related pain
- Known central nervous system or meningeal metastasis
- Clinically uncontrollable third-space fluid accumulation
- Grade 3 or higher hypersensitivity to monoclonal antibody treatments
- Use of systemic corticosteroids (≥10 mg prednisone or equivalent) or immunosuppressants within 2 weeks before dosing
- History or suspicion of interstitial lung disease or pneumonitis
- Severe pulmonary compromise or autoimmune disease
- Use of live attenuated vaccines within 28 days before dosing
- Unstable anticoagulant or thrombolytic use for more than 2 weeks before dosing
- Active or history of chronic inflammatory bowel disease
- Intestinal obstruction or risk of intestinal perforation within 3 months
- Major surgery or interventional treatment within 28 days before dosing
- Severe cardiovascular disease or uncontrolled severe illness
- History of immunodeficiency disease
- Active infections including HIV, tuberculosis, HBV, or HCV
- Other active malignancies requiring treatment
- Pregnancy or lactation in females of child-bearing potential
- Psychiatric illness or disorders affecting study compliance
- Investigator judgment deeming participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here