Actively Recruiting
A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
Led by LaNova Medicines Limited · Updated on 2025-09-25
320
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.
CONDITIONS
Official Title
A Phase I/II Study of LM-2417 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 study procedures
- Age between 18 and 80 years, male or female
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histological or cytological confirmation of recurrent or refractory advanced solid tumors
- Availability of archived or fresh tumor tissue specimens for testing
- At least one lesion that can be evaluated
- Adequate organ and marrow function based on lab tests within 7 days before first dose
- Women of childbearing potential must use highly effective contraception before, during, and for 6 months after treatment
- Ability to communicate well with investigators and follow study requirements
You will not qualify if you...
- Prior treatment with the same targeted therapy
- Participation in another interventional clinical trial within 28 days before first LM-2417 dose
- Anti-tumor treatment (radiotherapy, chemotherapy, endocrine therapy, immunotherapy) within 21 days before first LM-2417 dose
- Unresolved adverse events from prior therapy worse than grade 1 CTCAE v5.0
- Poorly controlled tumor-related pain
- Symptomatic or active central nervous system metastases
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Known allergy to antibody therapy
- Use of systemic corticosteroids (>10 mg prednisone daily) for more than 7 days or other immunosuppressants within 2 weeks before first LM-2417 dose
- Current or previous autoimmune disease
- Interstitial lung disease or history of pneumonitis needing glucocorticoids
- Live vaccine within 28 days before first LM-2417 dose
- Use of therapeutic doses of anticoagulants like heparin or vitamin K antagonists
- Major surgery or interventional treatment within 28 days before first LM-2417 dose
- History of severe cardiovascular disease
- Uncontrolled or severe illness
- HIV infection or active hepatitis B or C infection
- Other active invasive cancers within 5 years prior to screening
- Positive pregnancy test or breastfeeding in women of childbearing potential
- Psychiatric disorders affecting compliance
- Investigator judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
A
Alex Yuan
CONTACT
P
Paul Kong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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