A Study of the Safety and Efficacy of the Intravenous and Intratumoral Injection of OVV-01 in Patients With Advanced Solid Tumours.

NCT07648472 | Recruiting Phase 1 FDA Drug

• 1 other identifier: OVV-01A02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, dose escalation clinical study to evaluate the safety and preliminary efficacy of OVV-01 Injection in patients with advanced solid tumors, following both intravenous (iv.) and intratumoral (it.) injections. This study consists of two parts: Part 1 is a dose escalation study of iv. administration; Part 2 is a dose escalation study of iv. and it. administration.

Conditions

Advanced Solid Tumors

Keywords

OVV-01; VSV

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  The DLT observation period for both Route 1 and Route 2 is within the 4 weeks after the first dose.

Secondary Outcomes (2)

• Objective response rate (ORR)

  Tumor response should be assessed every 6 weeks following the first dose, with a final assessment conducted at the end of treatment (28 days after the last treatment).

• Disease control rate (DCR)

  Tumor response should be assessed every 6 weeks following the first dose, with a final assessment conducted at the end of treatment (28 days after the last treatment).

Study Arms (2)

OVV-01 iv.

ACTIVE COMPARATOR

Dose escalation of iv. administration "3+3" design is adopted to explore the MTD, based on which the RP2D will be determined.

Drug: OVV-01 Injection

OVV-01 iv.+it.

ACTIVE COMPARATOR

Dose escalation of iv.+it. administration "3+3" design is adopted to explore the MTD, based on which the RP2D will be determined.

Drug: OVV-01 Injection

Interventions

OVV-01 Injection DRUG

Dose group 1: 6×10 10 PFU/subject; Dose group 2: 6×10 11 PFU/subject;

OVV-01 iv.

Eligibility Criteria

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

You may qualify if:

• Be willing to sign the ICF, be able to understand the study, and be willing to follow the protocol and complete all the study procedures;
• Males or females aged ≥18 years when signing the ICF;
• Patients with advanced solid tumors (including but not limited to melanoma, squamous cell carcinoma of head and neck, cervix carcinoma, bone sarcoma, nasopharyngeal cancer, breast cancer, lung cancer, colorectal cancer, hepatic cancer, and gastric cancer) as histopathologically or cytologically confirmed by primary lesions and/or metastases; Patients with unresectable locally advanced disease will be included, while patients with resectable disease will be excluded.
• Patients who experienced treatment failure to standard of care, have no available standard of care, or are not suitable for standard of care due to medical reasons. Patients need to have progressed on at least two lines of standard of care therapy including but not limited to targeted therapy. For example, patients with metastatic or unresectable advanced melanoma who experienced treatment failure to standard of care such as anti-PD-1 antibody (patients harboring BRAF mutations who experienced treatment failure to BRAF and MEK inhibitors); patients with recurrent or metastatic advanced squamous cell carcinoma of head and neck who may have experienced standard treatment failure approved to anti-PD-1 monoclonal antibody and platinum-based chemotherapy; patients with recurrent or metastatic osteosarcoma who experienced treatment failure to chemotherapy drugs (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.); patients with colorectal cancer who have received standard of care fluoropyrimidine, oxaliplatin, Bevacizumab, and irinotecan-based chemotherapy, patients with wild-type KRAS who have received anti-EGFR, and patients with microsatellite instability-high disease who have received at least one prior immune checkpoint inhibitor; patients with breast cancer (including HR positive, HER2 +, and triple negative breast cancer) who have received at least 2 prior lines which should include taxane and/or anthracycline-based therapy where appropriate and an approved checkpoint inhibitor;
• Patients with at least one measurable lesion per RECIST v1.1, i.e., the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to computed tomography (CT) or magnetic resonance imaging (MRI); The patient should also have injected tumor lesions for Part 2, including cutaneous or subcutaneous visible nodal lesions or lesions palpable deemed injectable, and hepatic lesions or non-subcutaneous lymph nodes such as retroperitoneal. These lesions should be deemed feasible for injection either directly (palpable subcutaneous tumors) by a qualified investigator or under CT or ultrasound guidance (based on size, location, and visibility); All injected tumors should be \> 1 cm in size;
• Patients with an ECOG score of 0-1 and an expected survival of at least 12 weeks;
• Patients with adequate organ and hematopoietic function:
• ANC ≥1.5×10 9/L; Platelet count ≥75×10 9/L (no platelet transfusion or thrombopoietin \[TPO\] within 2 weeks prior to the first dose); Haemoglobin ≥90 g/L (no blood transfusion within 2 weeks); Serum creatinine ≤1.5×ULN or endogenous creatinine clearance (CCr) ≥50 mL/min; AST and ALT ≤3.0×ULN; AST and ALT ≤5×ULN for patients with liver metastases; Serum TBIL ≤2×ULN; International normalized ratio (INR) ≤1.5×ULN or activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Female patients of childbearing potential must have a negative pregnancy test result within 7 days prior to the study treatment;
• Male patients of reproductive potential and female patients of childbearing potential must agree to use a reliable contraceptive method during the study and at least 6 months after the last dose.

You may not qualify if:

• Patients with known brain metastases and/or clinically suspected brain metastases (however, patients with asymptomatic brain metastases or who have been clinically stable for more than 3 months after local treatment can be enrolled);
• Patients who received radiotherapy for the target lesion in the past 2 months;
• Patients with other active malignancies in the past 5 years shall be excluded, with the exceptions for those who are completely cured and do not require follow-up treatment, and those with study indications;
• The longest diameter of the injected lesion is \>100 mm for Part 2;
• Patients participated (in the past 4 weeks) or are participating in clinical studies of the other drugs or medical devices;
• Patients who plan to receive or received tissue or organ transplant;
• Patients with human immunodeficiency virus (HIV) infection and acquired immune deficiency (AID)-related opportunistic infection within 12 months, or CD4+ T-cell (CD4+) count \<350 cells/uL; patients with positive results for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), and a hepatitis B virus deoxyribonucleic acid (HBV-DNA) level higher than the lower limit of detection at screening; patients with positive result for hepatitis C virus (HCV) antibody and a hepatitis C virus ribonucleic acid (HCV-RNA) level higher than the lower limit of detection at screening; patients with positive serology result for treponema pallidum;
• Patients requiring antivirals during the study or those who are within 5 half-lives of antivirals at the time of the first dose of the study drug;
• Patients requiring therapeutic anticoagulation during the study;
• Patients with uncontrolled Grade ≥3 active infection and significant clinical relevance per CTCAE v5.0;
• Patients who received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 4 weeks prior to the first dose; small molecule targeted therapy and oral dose of fluorouracils within 2 weeks or 5 half-lives (whichever longer) prior to the first dose; Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose; nitrosourea or mitomycin C within 6 weeks prior to the first dose; however, patients who received palliative radiotherapy for non-target lesions are allowed (≥2 weeks prior to the first dose);
• Uncontrolled hypertension, pulmonary arterial hypertension or angina unstable; myocardial infarction, bypass or stent surgery within 6 months prior to the first dose; history of Grade 3-4 chronic heart failure according to New York Heart Association (NYHA) criteria; serious arrhythmia requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia that have no effect on the study as assessed by the investigator), including QTcF ≥450 ms for males and ≥470 ms for females (calculated by Fridericia's formula); cerebrovascular accident (CVA) or transient ischaemic attack (TIA) within 6 months prior to enrollment;
• Patients with active autoimmune disease or history of autoimmune disease that may relapse, however, patients with the following diseases are not excluded and may be further screened:
• Type 1 diabetes mellitus; Thyroid function decreased (if controlled with hormone replacement therapy only); Controlled coeliac disease; Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia); Any other disease that does not recur without an external triggering factor;
• Patients who require systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose or during the study, with the following exceptions:

Sponsors & Collaborators

• Joint Biosciences Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Ning Li

CONTACT

01067781331; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Dose escalation of iv. administration Part 2: Dose escalation of iv.+it. administration

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 15, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

CN (1)