- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758897
Clinical Study of VG161 in Subjects With Advanced Malignant Solid Tumors
A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of VG161 in Subjects With Advanced Malignant Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups.
Descriptive statistics will be used to summarize all data.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Shanghai
-
ShangHai, Shanghai, China
- Recruiting
- Shanghai East Hospital
-
ShangHai, Shanghai, China
- Recruiting
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
-
Contact:
- Wei Shen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females aged within 18 to 80 years.
- Subject with late stage carcinoma which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists.
- There is at lease one injectable tumor lesion that meet the requirements of the assigned dose level. The superficial lesions are preferred, and the deep lesions that can be injected under the guidance of B ultrasound or computed tomography (CT) scan can also be selected.
- Eastern Cooperative Oncology Group (ECOG) scores 0 or 1.
- Life expectancy is at least 3 months.
- Required organ function:
1) Hematology blood (no blood transfusion or colony stimulating factor treatment within 14 days): Absolute neutrophil count (ANC)≥1.5×10^9L, Platelets ( PLT)≥75×10^9L, hemoglobin (Hb)≥85g/L; 2) Liver function: Total Serum bilirubin (TBIL)≤1.5×ULN (the upper limit of the reference range), Alanine aminotransferase (ALT)≤3×ULN, aspartate aminotransferase (AST)≤3×ULN (acceptable for patients with liver metastasis or liver cancer: TBIL≤5×ULN, AST≤5×ULN, ALT≤5×ULN); 3) Renal function: Serum creatinine≤1.5×ULN, and creatinine clearance≥50 ml/min (calculated per Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT)≤1.5×ULN, international standardized ratio (INR)≤1.5×ULN.
7. Subjects of childbearing potential (male and female) must agree to use a reliable contraceptive method (hormone or barrier method or abstinence) during the study and for at least 90 days following the last dose; females of childbearing potential must have a negative blood or urine pregnancy test within 7 days of study enrollment.
8. Signed written informed consent.
Exclusion Criteria:
- Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation.
- Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.
- Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.
- Patients who received systemic treatment with either corticosteroids ( >10 mg/ daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
- Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).
- Subjects with any uncontrolled active Central Nervous System (CNS) metastasis or meningeal metastasis with clinical symptoms.
- Seronegative for Herpes Simplex Virus (HSV) (HSV-1IgG and HSV-1IgM).
- Subjects with the relapse of HSV infection and relevant clinical manifestations, such as lip herpes, herpes keratitis, herpes dermatitis, and genital herpes.
- Subjects with other uncontrolled active infections.
- Known history of immunodeficiency and test positive of human immunodeficiency virus (HIV).
- Active infection of hepatitis B (HBV) (hepatitis b virus titer higher than the detection limit or those requiring antiviral therapy), or hepatitis C virus (HCV).
- History of severe cardiovascular disease:
1)Ventricular arrhythmias requiring clinical intervention; 2)QTc interval >480 ms; 3)Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of III grade or above within 6 months; 4)The cardiac function grade≥II or left ventricular ejection fraction (LVEF) <50% per the New York Heart Association (NYA); 5)Uncontrolled hypertension. 13. Subjects with active or past autoimmune diseases that are likely to recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); acceptable for patients with clinically stable autoimmune thyroiditis.
14. Subjects with any prior ≥Grade 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent.
15. known to have alcohol or drug dependence. 16. Persons with mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Subjects with any significant unrelated systemic illness that to the investigator's opinion would compromise the subject's eligibility to participate the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Arm
|
Intratumoral injection only.
The dosing date can be the Day 1 only or Days 1 through 5.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD/RP2D
Time Frame: 1 month
|
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
|
1 month
|
Occurence of DLT
Time Frame: 1 month
|
Occurence of DLT (Dose Limiting Toxicity)
|
1 month
|
Numbers of DLT
Time Frame: 1 month
|
Numbers of DLT (Dose Limiting Toxicity)
|
1 month
|
Occurence of AE and SAE(NCI CTCAE 5.0)
Time Frame: 7 months
|
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
|
7 months
|
Frequency of AE and SAE(NCI CTCAE 5.0)
Time Frame: 7 months
|
Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax(h)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Time to peak
|
At the end of Cycle 1 (each cycle is 28 days)
|
Cmax(copies/ugDNA)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Maximum concentration
|
At the end of Cycle 1 (each cycle is 28 days)
|
ORR
Time Frame: 7 months
|
Evaluate Objective Response Rate by RECIST 1.1.
|
7 months
|
DCR
Time Frame: 7 months
|
Evaluate Disease Control Rate by RECIST 1.1.
|
7 months
|
mPFS
Time Frame: 7 months
|
Evaluate medium Progression Free Survival by RECIST 1.1.
|
7 months
|
CD3+, CD4+, CD8+
Time Frame: 7 months
|
Concentration of CD3+, CD4+, CD8+
|
7 months
|
IL15
Time Frame: 7 months
|
Concentration of IL15
|
7 months
|
PD-L1, PD-1
Time Frame: 7 months
|
Concentration of PD-L1, PD-1,
|
7 months
|
Existence of Biomarkers
Time Frame: 4 months
|
PD-L1, Nectin2, HVEM
|
4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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