Actively Recruiting
Study of LM-299 in Subjects Advanced Malignant Tumors
Led by LaNova Medicines Limited · Updated on 2025-05-02
108
Participants Needed
6
Research Sites
142 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-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours.. For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.
CONDITIONS
Official Title
Study of LM-299 in Subjects Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent before any study procedure
- Aged between 18 and 80 years at the time of consent
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Diagnosed advanced solid tumors confirmed by biopsy or pathology, with failure or intolerance to standard treatments or unsuitability for standard treatment
- Able to provide pre-treatment archived tumor tissue (within 5 years) or fresh samples for biomarker analysis
- At least one measurable tumor lesion according to RECIST v1.1
- Adequate organ and bone marrow function as defined by the study protocol
- Female participants of childbearing potential or males with partners of childbearing potential agree to use highly effective contraception
- Able to communicate well with investigators and understand and follow study requirements
You will not qualify if you...
- Participation in another clinical trial within 28 days before first dose of LM-299
- Received anti-tumor treatments within specified time periods before first dose
- Any unresolved adverse events from prior therapy above grade 1 (CTCAE v5.0)
- Uncontrolled tumor-related pain
- Known central nervous system or meningeal metastasis
- Urine protein results of 3+ or higher
- Significant hemoptysis or tumor bleeding within 2 weeks before first dose
- Life-threatening bleeding events within 3 months before first dose
- Esophageal or gastric varices requiring immediate intervention or history of variceal bleeding
- Hepatic encephalopathy, hepatorenal syndrome, or severe liver cirrhosis (Child-Pugh class B or worse)
- Clinically uncontrollable third-space fluid accumulation
- Tumor invading vital organs or risk of fistula or intratumoral cavity on imaging
- History of gastrointestinal perforation or fistula within 6 months before first dose
- Complete or incomplete intestinal obstruction within 3 months before first dose or risk of intestinal perforation
- Known allergy to antibody treatments
- Use of systemic corticosteroids ≥10 mg/day prednisone or equivalent for more than 7 days within 2 weeks before first dose
- History of autoimmune disease
- History or current inflammatory bowel disease requiring systemic corticosteroid treatment
- Received live or attenuated vaccines within 28 days before first dose
- Current use of anticoagulants such as therapeutic heparin or vitamin K antagonists
- Major surgery or interventional treatment within 28 days before first dose (excluding biopsy or puncture)
- Severe cardiovascular or cerebrovascular diseases
- Severe infections within 4 weeks before first dose
- History of immunodeficiency
- HIV infection, active hepatitis B or C infection
- Known active tuberculosis or suspected active tuberculosis
- Other malignancies within 5 years before first dose
- Positive pregnancy test within 7 days before first dose or breastfeeding
- Psychiatric disorders affecting study adherence
- Local or systemic diseases caused by non-malignant tumors
- Judged ineligible by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
One Clinical Research
Perth, Western Australia, Australia
Not Yet Recruiting
2
the first affiliated hospital of Xinxiang medical University
Xinxiang, Henan, China
Not Yet Recruiting
3
Liaocheng people's hospital
Liaocheng, Shandong, China
Not Yet Recruiting
4
Zibo municipal hospital
Zibo, Shandong, China
Not Yet Recruiting
5
Shanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital)
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
A
Alex Yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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