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

NCT06508307 | Recruiting Phase 1

• 1 other identifier: GONGCHU
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma; Cervical Cancer; Colon Cancer; Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Hepatocellular Carcinoma; Breast Cancer; Gastric Cancer

Keywords

GC001、Oncolytic virus 、WR

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of GC001

  Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs)，treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

  DLT Observation Period，Up to 28 days from GC001 injection

• Maximal tolerable dose

  During the DLT observation period, the number of cases with DLT is less than or equal to the maximum dose of 1/6 of the total number of cases, and six evaluable participants are required to determine MTD.

  DLT Observation Period,Up to 28 days from GC001 injection

Secondary Outcomes (4)

• Anti-tumor activity of GC001: overall response rate (ORR).

  Up to 2 years

• Anti-tumor activity of GC001: duration of response (DOR).

  Up to 2 years from GC001 injection

• Anti-tumor activity of GC001:progression-free survival (PFS).

  Up to 2 years from GC001 injection

• Evaluate the viral biological distribution and shedding of GC001

  Up to 2 years from GC001 injection

Other Outcomes (3)

• Pharmacodynamic analysis of immune cells in the peripheral blood

  Up to 2 years from GC001 injection

• Pharmacodynamic analysis of cytokine levels in the peripheral blood.

  Up to 2 years from GC001 injection

• immunogenicity

  Up to 2 years from GC001 injection

Study Arms (1)

Part 1: Dose Escalation

EXPERIMENTAL

The study consists of a total of six dose groups, with the lowest dose group being 3×10\^6 and the highest dose reaching 1×10\^9 PFU. In case the maximum dose of 1×10\^9 PFU fails to achieve the Maximum Tolerated Dose (MTD), the Safety Monitoring Committee (SMC) will convene to discuss whether to designate it as Maximum Feasible Dose (MFD) or consider escalating further based on current safety and preliminary efficacy data. However, any escalation beyond that of similar drugs' Phase I clinical trials, such as JX-594:NCT00629759 and JX-929:NCT00574977, where the highest administered dose was 3×10\^9 PFU, shall be avoided. This precaution ensures adherence to established safety protocols. A single dose of GC001 will be administered up to 4mL (The injection volume is based on the length of the lesion).

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

Interventions

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

The maximum number of lesions that each participant is allowed to inject at one time is two.

Part 1: Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).
• 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.
• 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 having received a blood transfusion for at least 7 days);
• 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.

You may not qualify 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 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.
• 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 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.
• 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.
• 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:
• 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 CNS-targeted treatments for at least 4 weeks) may be eligible for enrollment.
• Individuals with clinically significant or rapidly accumulating ascites, pericardial and/or pleural effusions.
• A history of severe cardiovascular disease, including but not limited to:

Sponsors & Collaborators

• GONGCHU Biotechnology Co., Ltd: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Sarcoma; Uterine Cervical Neoplasms; Colonic Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Carcinoma, Hepatocellular; Breast Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Liver Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stomach Diseases

Study Officials

• li gongchu, Professor

  GONGCHU Biotechnology Co., Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mo guoyu

CONTACT

13710803863; morlon_pla@126.com

luo suxia, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3+3

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 18, 2024
• Study Start: April 26, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)