Actively Recruiting
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors
Led by LaNova Medicines Limited · Updated on 2024-12-19
139
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors
CONDITIONS
Official Title
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and able to sign informed consent
- Aged 18 years or older, any gender
- 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 that progressed after standard therapy
- At least one measurable tumor lesion
- Archived or fresh tumor tissue available for testing if in combination therapy group
- Adequate organ and marrow function within 7 days before first dose
- Women of childbearing potential must agree to use effective contraception during and for 6 months after treatment
- Able to communicate with investigators and follow study requirements
You will not qualify if you...
- Prior investigational therapy targeting the same treatment
- Participation in another interventional clinical trial within 21 days before first LM-101 dose
- Anti-tumor treatment including radiotherapy, chemotherapy, endocrine or immunotherapy within 21 days before first LM-101 dose
- Unresolved adverse events from prior anti-tumor therapy above grade 1
- Poorly controlled tumor-related pain
- Symptomatic or active central nervous system metastases
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Known allergy to antibody therapy
- Use of systemic corticosteroids over 10 mg prednisone daily or immunosuppressants within 2 weeks before first LM-101 dose
- History of autoimmune disease except stable hypothyroidism on thyroid hormone
- Interstitial lung disease or pneumonitis requiring glucocorticoids
- Use of live attenuated vaccines within 28 days before first LM-101 dose
- Use of therapeutic anticoagulants like heparin or vitamin K antagonists
- Major surgery or interventional treatment within 28 days before first LM-101 dose, except biopsy or puncture
- History of severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency
- HIV, active tuberculosis, or active hepatitis B or C infection
- Other active invasive cancers within 5 years prior to screening
- Positive pregnancy test or lactating females
- Known psychiatric conditions affecting study compliance
- Deemed ineligible by investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
3
Linyi Cancer Hospital
Linyi, Shandong, China
Not Yet Recruiting
4
Beijing Tongren Hospital, CMU
Beijing, China
Terminated
5
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
A
Alex Yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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