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진행성 고형암 환자를 대상으로 하는 종양 내 주사 용해성 백시니아 바이러스 GC001의 1상 임상시험

A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors

안내

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항목 내용
등록번호 NCT06508307
상태 모집 중
단계 1상
시험 약물/중재 A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors
대상 질환 Sarcoma, Cervical Cancer, Colon Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
스폰서 GONGCHU Biotechnology Co., Ltd
연령·성별 18 Years ~ 75 Years · ALL
목표 인원 21
시작 / 1차 완료 예정 2023-04-26 / 2026-01
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (China)
결과 게시 아니오
최근 갱신 2025-08-21

문의처 (등록된 중앙 연락처)

  • Mo guoyu 13710803863 morlon_pla@126.com
  • luo suxia, Professor

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요

본 임상시험은 진행성 고형암 환자를 대상으로 종양 내 바이러스 주사제인 GC001의 안전성, 내약성, 바이러스 분포 및 배출 양상, 약동학, 면역원성, 그리고 항종양 효과를 평가하기 위한 공개, 단일군, 1상 연구입니다. 3+3 설계를 통해 용량증가(dose escalation) 단계를 거치며, 용량제한독성(DLT) 관찰 기간은 투여 후 28일입니다. 예상 등록 환자 수는 21명에서 36명입니다.

  • 목표 인원은 21명에서 36명의 진행성 고형암 환자입니다.
  • 투여 후 28일 동안 용량제한독성(DLT)과 최대내용량(MTD) 등을 평가합니다.
  • 초록에 항종양 효과의 구체적인 수치는 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: 1. 18세에서 75세의 성인 남녀 환자. 2. 표준 치료가 없거나 효과가 없는 조직학적 또는 세포학적으로 진단된 진행성 고형암 환자. 3. RECIST v1.1 기준에 따라 종양 내 주사가 가능한 적어도 하나의 두 개 내 측정이 가능한 병변 보유. 4. 동유럽종양학협회(ECOG) 신체 상태 점수 0 또는 1점. 5. 예상 생존 기간이 최소 3개월 이상인 환자. 6. 적절한 골수 및 장기 기능을 갖춘 환자.

제외 기준: 1. 첫 투여 전 5년 이내에 다른 악성 종양의 병력이 있는 환자 (전이 위험이 낮은 기저세포암 등 제외). 2. 임산부 또는 수유부. 3. 유사 제품 또는 부형제에 대한 알레르기(2개 이상의 약물 알레르기)가 있는 자. 4. 천연두 백신 접종 후 심각한 전신 반응이 있었던 자. 5. 이전에 용해성 바이러스, 줄기세포, 유전자 치료 제품을 투여받은 적이 있는 자. 6. 첫 투여 전 28일 이내에 다른 임상시험용 약물이나 항종양 치료를 받은 자. 7. 첫 투여 전 28일 이내에 수술, 중재적 치료를 받았거나 치유되지 않은 상처가 있는 자. 8. 최근 6개월 이내에 심각한 심혈관계 질환 또는 3등급 이상의 출혈 이력이 있는 환자.

선정/제외 기준 원문 (영어)

Inclusion Criteria:

To be eligible for participation in this study, individuals must meet the following criteria:

  1. 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.
  2. Be male or female patients aged 18 to 75 years (including those with borderline age values).
  3. 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 either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).
  4. 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 v1.1 criteria.
  5. Have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.
  6. Be expected to survive for at least 3 months.

  7. Within 7 days prior to receiving the first dose of treatment, patients must meet the following organ function and bone marrow reserve:

  8. 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 having received a blood transfusion for at least 7 days);

  9. Coagulation function: INR ≤ 1.2, APTT ≤ 1.2 × ULN (upper limit of normal), PT ≤ 1.2 × ULN;
  10. Hepatic function: total bilirubin ≤ 1.5
  11. × 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);
  12. Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (according to the Cockcroft-Gault formula, see Appendix 2 for details);
  13. Cardiac function: QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male.
  14. Ability to effectively communicate with the investigator and comprehend and adhere to the requirements of the study.

Exclusion Criteria:

  1. 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 treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.
  2. Females of childbearing age who have a positive pregnancy test or are lactating.
  3. Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
  4. Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
  5. Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
  6. 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).
  7. 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 of the drug; Individuals using small molecule targeted agents with antitumor effects within 14 days prior to the first administration of the drug or within 5 times the half-life of the drug (whichever is longer); Individuals using herbal medicines with antitumor effects within 14 days prior to the first administration of the drug.
  8. Individuals who have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, etc.), or have unhealed wounds, ulcers, or fractures within 28 days prior to the first dose.

  9. 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 antiviral medications (such as ribavirin, rifampin, imatinib, etc.), enrollment is permitted under the following cases:

  10. short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;

  11. the use of topical topical or inhaled glucocorticoids is permitted;
  12. patients with hepatitis B who are stable while receiving antiviral medications.
  13. 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 CNS-targeted treatments for at least 4 weeks) may be eligible for enrollment.
  14. Individuals with clinically significant or rapidly accumulating ascites, pericardial and/or pleural effusions.

  15. A history of severe cardiovascular disease, including but not limited to:

    1. evere cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring medical intervention, II-III degree atrioventricular block, etc;
    2. According to the standards of the New York Heart Association (NYHA), individuals with grade III-IV heart failure;
    3. 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 first administration;
    4. Uncontrolled hypertension despite standard antihypertensive therapy, with blood pressure persistently above systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg.

  16. 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 vessel, or active peptic ulcer, or esophageal varices judged by the investigator to be at significant risk for bleeding.

  17. Those with a history of severe hemoptysis。
  18. 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).
  19. Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.

  20. Subjects 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 sclerosis, vasculitis, glomerulonephritis, etc.) or at high risk (e.g., patients who have undergone organ transplantation requiring immunosuppressive therapy) are not eligible for enrollment. However, enrollment is permitted for subjects with:

    1. type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;
    2. autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy.

  21. Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded。

  22. Persons who are positive for human immunodeficiency virus (HIV) antibodies.
  23. Persons who have active hepatitis B (HBV)/hepatitis C (HCV) infection are not eligible for enrollment. However, subjects with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those who are HBsAg positive but have HBV DNA \<500 IU/ml or below the lower limit of detection at the study center may also be enrolled. Subjects with primary liver cancer and HBV DNA \<1000 IU/ml may be enrolled as well.
  24. 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) throughout the study period and during the safety follow-up period are excluded.
  25. Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.
  26. Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.
  27. 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 neurovascular structures, or airways, or tumors in locations that present a high risk of adverse events or are unsuitable for intratumoral injections.

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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