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A Phase II Trial of LM103 in Advanced Melanoma
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2026-05-12
92
Participants Needed
13
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A total of 92 subjects with advanced melanoma who met the inclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group and the control group in this phase II trial. The study will be followed up until 24 months after treatment.
CONDITIONS
Official Title
A Phase II Trial of LM103 in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at informed consent
- Expected survival time longer than 3 months
- ECOG performance status of 0 or 1
- Unresectable recurrent or metastatic melanoma excluding uveal melanoma
- Failure or intolerance to PD-1 antibody treatment
- If BRAF V600 mutation positive, failure of BRAF and/or MEK inhibitors
- If NRAS mutation positive, failure of Tunlametinib treatment
- Presence of lesions available for surgery or biopsy
- At least one measurable lesion after tumor tissue resection or biopsy
- Adequate blood and organ function
- Signed informed consent form voluntarily
You will not qualify if you...
- History of other cancers in the past 5 years except certain well-treated cancers
- Unresolved adverse reactions from previous treatments except specific exceptions
- Severe immune-related adverse reactions from prior immunotherapy
- Vaccination within 2 months before tumor tissue surgery or planned vaccination during the study
- TIL, allogeneic T cell, or NK cell therapy within 6 months before consent
- Previous allogeneic stem cell or solid organ transplant
- Active brain metastases or cancerous meningitis except stable treated brain metastases
- Active or suspected autoimmune diseases
- Large symptomatic pleural effusion or ascites requiring treatment
- Current or past irreversible interstitial lung disease
- Serious heart or brain blood vessel diseases
- Active infections requiring systemic treatment
- Infectious diseases like hepatitis B, C, syphilis, or AIDS
- Esophageal or gastric varices needing immediate intervention or high bleeding risk
- Uncontrolled metabolic or other non-cancer diseases increasing medical risk
- Known allergy to LM103 or its components
- Pregnant or breastfeeding women
- Other severe medical, mental, or laboratory conditions increasing participation risk or affecting results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Beijing Go Broad Hospital
Beijing, Beijing Municipality, China
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2
Fujian Cancer Hospital
Fuzhou, Fujian, China
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3
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
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4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
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5
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
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6
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
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7
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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8
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
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9
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
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10
West China Hospital of Sichuan University
Chengdu, Sichuan, China
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11
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
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12
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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13
Beijing Cancer Hospital
Beijing, China
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Research Team
J
Jun Guo, Prof. Dr. Med
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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