Oncolytic Virus (OVV-01) Injection in the Treatment of Patients With Advanced Solid Tumors

NCT04787003 | Unknown Phase 1

• 1 other identifier: RR-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ia: To investigate the safety, tolerability and efficacy of OVV-01 injection in the treatment of patients with advanced solid tumors (OVV-01 single dose gradient exploration). Phase Ib: To evaluate the safety, tolerability and efficacy of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in the treatment of patients with advanced solid tumors (OVV-01 combined with PD-1/PD-L1 monoclonal antibody dose gradient exploration); Phase Ic: A cohort expansion of Phase Ib to further analyze the efficacy and safety of OVV-01 injection combined with immune checkpoint inhibitor injection in the treatment of advanced solid tumors.

Conditions

Neoplasms

Keywords

Oncolytic Virus Injection; Intratumoral Injection; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (2)

• to define the MTD of OVV-01

  to define the maximum tolerated dose (MTD) of intratumoral administration of OVV-01 injection in humans with malignant tumors.

  6 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  to evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in patients with advanced solid tumors.

  8 months

Secondary Outcomes (2)

• To evaluate the efficacy assessed by the RECISTv1.1 of OVV-01

  6 months

• To evaluate the efficacy assessed by the RECISTv1.1 of OVV-01 with ICIs

  8 months

Study Arms (1)

Oncolytic virus (OVV-01) injection for patients with advanced solid tumors

EXPERIMENTAL

Oncolytic virus (OVV-01) injection combined with or without immune checkpoint inhibitors in the treatment of patients with advanced solid tumors.

Drug: oncolytic virus (OVV-01) injection

Interventions

oncolytic virus (OVV-01) injection DRUG

intratumoral injection of OVV-01 with or without immune checkpoint inhibitors

Also known as: C045

Oncolytic virus (OVV-01) injection for patients with advanced solid tumors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 18 and ≤ 70 years;
• Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary tumor and/or metastases, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer;
• Patients for the third-line or higher standard therapy failed;
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
• ECOG score of 0 \~ 2;
• Expected survival ≥ 3 months;
• Adequate bone marrow function;
• WBC ≥ 3.0 × 109/L;
• Neutrophils (ANC) ≥ 1.5 × 109/L;
• Lymphocyte count ≥ 6.0 × 108/L
• Platelets ≥ 90 × 109/L without transfusion within 14 days prior to starting the first cell therapy;
• Hemoglobin ≥ 10.0 g/dL
• Adequate hepatic and renal function:
• Total bilirubin ≤ 1.5 × ULN.
• AST and ALT \< 2.5 × ULN; \< 5 × ULN AST for patients with liver metastases;

You may not qualify if:

• Subjects without measurable lesions;
• Subjects with known brain metastasis and/or clinically suspected tumor brain metastasis (patients with asymptomatic brain metastasis or clinically stable for more than 3 months after local treatment can be excluded);
• Subjects who have received radiotherapy for target lesion within 2 months;
• Subjects with other active malignancies requiring concurrent treatment;
• Subjects with known hypersensitivity to the investigational drug or its active ingredients and excipients;
• Subjects who have received or are still receiving treatment with other investigational drugs or antiviral therapy 4 weeks before randomization;
• Subjects preparing for or having received tissue/organ transplantation preciously;
• Subjects having any active infection or unexplained fever \> 38.5℃ during the screening period, prior to the first dose;
• Subjects with active pulmonary tuberculosis (TB) who are receiving anti-TB treatment or who have received anti-TB treatment within 1 year before screening;
• Subjects with positive result of serological test for Treponema pallidum;
• Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
• Subjects with active hepatitis. Hepatitis B: hepatitis B virus surface antigen (HBVs Ag) positive or HBVsAg negative, but anti-HBVc positive and HBV DNA test value higher than the upper limit of normal; hepatitis C: hepatitis C virus antibody (HCV Ab) positive and HCV RNA positive; with hepatitis B and C co-infection;
• Cardiovascular system disorders meeting any of the following:
• Congestive heart failure with cardiac function ≥ NYHA III;
• Serious arrhythmia requiring medication;

Sponsors & Collaborators

• North China Petroleum Bureau General Hospital: lead
• Joint Biosciences Ltd: collaborator

Study Sites (1)

North China Petroleum Bureau General Hospital

Cangzhou, Hebei, 062552, China

RECRUITING

Related Publications (1)

• Hua Y, Wang C, Li F, Han Y, Zuo D, Lv Y, Sun M, Yuan P, Yuan R, Zhang F, Ma L, Wang Y, Wu H, Zhou G, Lin Q, Wang S, Li N, Lu Y; North China Petroleum Bureau General Hospital. Phase 1, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors. J Immunother Cancer. 2025 Jun 5;13(6):e011517. doi: 10.1136/jitc-2025-011517.

  PMID: 40480657 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Qiang Lin, Ph.D

  North China Petroleum Bureau General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan-hua Bi, M.D

CONTACT

+86-317-272-8295; zyy_byh@petrochina.com.cn

Study Design

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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: February 16, 2021
• Primary Completion: October 1, 2023
• Study Completion: February 28, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the publication of this study IPD could be shared.The sharing time is set for 5 years
• Access Criteria: For the purpose of academic research only

Locations

CN (1)