Actively Recruiting
A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
Led by ImmuneOncia Therapeutics Inc. · Updated on 2026-04-17
30
Participants Needed
4
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.
CONDITIONS
Official Title
A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented tumor mutational burden high (TMB-H) of 16 mutations per megabase or higher by specific genetic tests
- Histologically or cytologically confirmed metastatic or locally advanced solid tumors with at least one measurable lesion
- Investigator confirmation that tumor tissue is available for central pathology review
- Adult age as defined by respective country
- Voluntary agreement to participate with signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prior systemic radiation therapy completed at least 4 weeks before first study drug dose
- Prior focal radiotherapy completed at least 2 weeks before first study drug dose
- At least 28 days since last chemotherapy, immunotherapy, biologic, or investigational therapy with recovery to less than Grade 2 toxicity
- Adequate blood, liver, and kidney function
- Female participants must be postmenopausal, surgically sterile, or agree to use reliable contraception during and for 90 days after treatment
- Male participants must agree to use barrier contraception during and for 90 days after treatment
- Predicted life expectancy of at least 16 weeks
You will not qualify if you...
- Previous treatment with anti-PD-L1 or anti-PD-1 antibody
- Presence of symptomatic central nervous system metastases
- Any active or history of autoimmune disease
- Active viral infections including HIV, hepatitis B, or hepatitis C
- Pregnant or lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
National Cancer Center
Goyang, South Korea
Actively Recruiting
2
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
3
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
4
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
SUNGYOUNG LEE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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