Actively Recruiting
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
Led by GeneMedicine Co., Ltd. · Updated on 2024-03-21
125
Participants Needed
4
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include:
CONDITIONS
Official Title
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or over at the time of signing informed consent
- Diagnosis of locally advanced, unresectable, refractory, or metastatic solid tumors
- Tumor accessible and willing to consent to tumor biopsies during the study
- At least one measurable site of disease by RECIST 1.1 criteria, measurable by CT or MRI
- At least one intratumorally injectable lesion suitable for repeated measurement by imaging or clinical exam
- For dose expansion cohorts, paired pre- and on-treatment tumor biopsies available for safely accessible metastases
- Brain metastases must be stable, neurologically asymptomatic, and not require corticosteroids
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Predicted life expectancy of 12 weeks or more
- Able to comply with study procedures
- Adequate organ function within 4 weeks prior to screening
- Male or female patient
- Women must use contraception consistent with local regulations
- Capable of giving signed informed consent
You will not qualify if you...
- Known history of HIV/AIDS or taking related medications
- Use of systemic corticosteroids (>10 mg daily prednisolone equivalent) or immunosuppressive medications within 14 days before first dose
- History or active autoimmune disease requiring systemic immunosuppression
- Active infections needing antibiotics or associated with recurrent fevers >38.0 C
- History of seizures, central nervous system abnormalities, mental disorders, or heart disease
- History of pleural effusion, pulmonary embolism, or intestinal obstruction
- Systemic anticancer therapy within 4 weeks or 6 half-lives before study treatment
- Prior treatment with GM103 or other oncolytic viruses
- Radiation therapy within 2 weeks before enrollment
- Antiviral agents within 7 days or pegylated interferon within 14 days before first dose
- Live vaccine within 30 days before study enrollment
- Serious or uncontrolled medical disorders increasing risk or interfering with study
- Participation in other clinical trials within 4 weeks before first dose
- Investigational drug use within 28 days before first dose
- Ejection fraction of 50% or less by MUGA scan or echocardiogram
- Major surgery within 4 weeks before enrollment
- Inability or unwillingness to follow study procedures
- Any serious medical condition or abnormal clinical laboratory test results
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-si, Gyeonggi-do, South Korea, 10408
Not Yet Recruiting
2
Korea University Anam Hospital
Seoul, South Korea, 02841
Not Yet Recruiting
3
Hanyang University Seoul Hospital
Seoul, South Korea, 04763
Not Yet Recruiting
4
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
K
KyoungRyun Park
CONTACT
Y
YunJoo Lee
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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