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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2024
  • participants needed
    50
  • sponsor
    North China Petroleum Bureau General Hospital
Updated on 9 July 2021
carcinoma
breast cancer
bone marrow procedure
primary cancer

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.

Description

Phase Ia:

This is a prospective, multicenter, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection in patients with advanced solid tumors.

This study plans to enroll in 1 ~ 3 study sites nationwide about 9 ~ 18 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ia study, i.e., the First in Human (FIH) trial of OVV-01 injection, using the traditional "3 + 3" approach for dose gradient exploration.

Phase Ib:

This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.

This study plans to enroll in 1 ~ 3 study sites nationwide about 12 ~ 24 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ib study, using the traditional "3 + 3" approach and based on the phase Ia results, 2 dose gradients of OVV-01 are used in combination with pembrolizumab and atezolizumab, respectively, to explore the efficacy and safety.

Phase Ic:

This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.

This study plans to enroll in 1 ~ 3 study sites nationwide about 15 ~ 20 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ic study.

Details
Condition Cancer/Tumors, Neoplasms, Cancer, Ewing's Family Tumors, Cancer (Pediatric)
Treatment oncolytic virus (OVV-01) injection
Clinical Study IdentifierNCT04787003
SponsorNorth China Petroleum Bureau General Hospital
Last Modified on9 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 8. Adequate hepatic and renal function
Total bilirubin 1.5 ULN
AST and ALT < 2.5 ULN; < 5 ULN AST for patients with liver metastases
Blood creatinine 1.5 ULN, or creatinine clearance rate 50 ml/min (calculation with Cockcroft/Gault formula) 9. Coagulation function
INR 1.5 ULN
PTT 1.5 ULN 10. Adequate cardiovascular function
Epilepsy score (EF) 50%
QTcF interval 450 ms 11. Women of childbearing age who have a negative pregnancy test within 14 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method (such as surgical sterilization, oral contraceptives, intrauterine device, sexual abstinence or barrier contraception combined with spermicide, etc.) during study treatment and within at least 6 months after the last dose of investigational drug; 12. The patients voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up

Exclusion Criteria

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
Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass grafting or stenting within 6 months prior to the first dose
Left ventricular ejection fraction (LVEF) < 50%
Corrected QTc interval > 450 ms for males and > 470 ms for females, or presence of risk factors for torsades de pointes such as clinically significant hypokalemia, family history of long QT syndrome or family history of arrhythmia (e.g., Wolff-Parkinson-White syndrome) as judged by the investigator
Hypertension not effectively controlled (defined as systolic blood pressure 140 mmHg and/or diastolic blood pressure 90 mmHg after standardized antihypertensive drug therapy)
Patients with active autoimmune diseases or history of autoimmune diseases that may relapse, but patients with the following diseases are not excluded, may be further
screened
Type 1 diabetes
Hypothyroidism (if controlled with hormone replacement therapy alone)
Controlled celiac disease
Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
Any other disease that will not recur in the absence of external triggers
Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days prior to investigational drug administration, but currently or previously treated with any of the following steroid regimens, were included
Adrenaline replacement steroid (prednisone 10 mg/day or equivalent of the similar drug)
Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption
Prophylactic short-term ( 7 days) use of corticosteroids (e.g., allergy to contrast media) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens)
Subjects having mental illness, alcoholism, inability to quit smoking or drug abuse
Female subjects who are pregnant or lactating, or expecting to become pregnant during the trial (from the screening visit until 180 days after dosing) and male subjects who are expecting to father children
Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia)
Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator
Subjects in other conditions that are considered unsuitable for this study by the investigator
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