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New treatment option for Sarcoma
Official title A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06508307
What this study is testing
What is A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors?
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- To be eligible for participation in this study, individuals must meet the following criteria:
- Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent...
- Be male or female patients aged 18 to 75 years (including those with borderline age values).
- Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have...
- Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed...
You likely can't join if
- Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of...
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
- Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
- Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
- Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for...
See the full eligibility criteria
Who can join
- To be eligible for participation in this study, individuals must meet the following criteria:
- Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent by signing the form prior to undergoing any procedures.
- Be male or female patients aged 18 to 75 years (including those with borderline age values).
- Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have been histologically or cytologically diagnosed and for which there is...
- Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed consent form) that is suitable for intratumoral injection based on RECIST...
- Have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.
- Be expected to survive for at least 3 months.
- Within 7 days prior to receiving the first dose of treatment, patients must meet the following organ function and bone marrow reserve:
- Hematology: platelets (PLT) ≥ 80 × 109/L, neutrophil count (ANC) ≥ 1.5 × 109/L, and hemoglobin ≥ 9 g/dL (without having received adjuvants like EPO, G-CSF, or GM-CSF in the 14 days leading up to the first dose, and not...
- Coagulation function: INR ≤ 1.2, APTT ≤ 1.2 × ULN (upper limit of normal), PT ≤ 1.2 × ULN;
- Hepatic function: total bilirubin ≤ 1.5
- × ULN (patients with Gilbert syndrome may be enrolled with a total bilirubin ≤ 3 × ULN), AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of hepatic metastases);
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (according to the Cockcroft-Gault formula, see Appendix 2 for details);
- Cardiac function: QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male.
- Ability to effectively communicate with the investigator and comprehend and adhere to the requirements of the study.
What rules you out
- Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival \> 90%), such as adequately...
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
- Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
- Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
- Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).
- Those who have undergone antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration...
- Individuals who have undergone surgery or treatment therapy (excluding tumor biopsy, puncture, etc.), or have unhealed wounds, ulcers, or fractures within 28 days prior to the first dose.
- Individuals who have been treated with systemic corticosteroids (at a dose equivalent to \>10 mg prednisone/day) or other immunosuppressive medications within 28 days prior to the first dose, or who are currently taking...
- short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;
- the use of topical topical or inhaled glucocorticoids is permitted;
- patients with hepatitis B who are stable while receiving antiviral medications.
- Patients with clinically symptomatic CNS metastases or poorly controlled CNS metastases despite treatment (patients who have been stable for more than 4 weeks by MRI/CT without requiring steroidal medications or other...
- Individuals with clinically significant or rapidly accumulating ascites, pericardial and/or pleural effusions.
- A history of severe cardiovascular disease, including but not limited to:
- evere cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring medical intervention, II-III degree atrioventricular block, etc;
- According to the standards of the New York Heart Association (NYHA), individuals with grade III-IV heart failure;
- Recent cardiovascular events such as acute coronary syndrome, congestive heart failure, aortic dissection, stroke, cerebrovascular malformation, or other Grade 3 or higher events within the past 6 months prior to the...
- Uncontrolled hypertension despite standard antihypertensive therapy, with blood pressure persistently above systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg.
- Recent Grade 3 or greater bleeding event within 6 months prior to the first use of study drug, or who have current \> Grade 2 bleeding, or hemangioma/vascular malformation, or tumor stroke, tumor invasion of a blood...
- Those with a history of severe hemoptysis。
- Adverse effects from prior antineoplastic therapy that have not recovered to a CTCAE v5.0 grade rating of ≤ 1 (excluding non-risky toxicities like alopecia).
- Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.
- people with active or prior history of autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple...
- type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;
- autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy.
- Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded。
- Persons who are positive for human immunodeficiency virus (HIV) antibodies.
- Persons who have active hepatitis B (HBV)/hepatitis C (HCV) infection are not eligible for enrollment. However, people with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those...
- Male and female patients who refuse to use an appropriate method of contraception, (such as the simultaneous use of spermicides, barrier contraceptives, and/or intrauterine contraceptives, as outlined in Appendix 1)...
- Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.
- Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.
- Patients who, as determined by the investigator, are unsuitable for participation in the study, including those with tumors surrounding major vascular structures such as the carotid arteries, tumors adjacent to critical...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.