OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors

NCT07650825 | Not Yet Recruiting Phase 1

• 1 other identifier: OVV-01A07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

oncolytic virus; immunotherapy

Outcome Measures

Primary Outcomes (2)

• DLT

  According to the internationally accepted CTCAE v5.0 toxicity grading criteria, DLT in this study is defined as a toxicity reaction related to the study drug OVV-01 occurring within 3 weeks after the first dose.

  Within 21 days after administration

• Incidence of Adverse Events (AEs)

  Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.

  From signing ICF until 24 months after the last infusion.

Secondary Outcomes (5)

• ORR

  Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

• DCR

  Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

• DoR

  Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

• PFS

  Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

• OS

  Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

Study Arms (2)

OVV-01 intravenous injection

EXPERIMENTAL

OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; Upon enrollment of 3 subjects in the OVV-01 monotherapy intravenous group with no DLT events, the combination therapy group may be initiated; In the combination therapy group, OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered.

Drug: OVV-01; Drug: AK112

OVV-01 IV + IT

EXPERIMENTAL

OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; intratumoral injection and intravenous injection are completed on the same day. The OVV-01 monotherapy intravenous group may initiate the combination therapy group once 3 subjects are enrolled and no DLT events occur. For the combination therapy group: OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered. Intratumoral injection and intravenous injection are completed on the same day.

Drug: OVV-01; Drug: AK112

Interventions

OVV-01 DRUG

OVV-01 is administered twice every two weeks

OVV-01 IV + IT; OVV-01 intravenous injection

AK112 DRUG

AK112 is administered once every two weeks.

OVV-01 IV + IT; OVV-01 intravenous injection

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at the time of signing the ICF; gender is not restricted.
• Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary and/or metastatic lesions, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, etc.
• Patients with advanced disease who have failed standard therapy, lack standard treatment options, or are medically ineligible for standard therapy. Patients must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies).
• Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions ≥10 mm in longest diameter and lymph node lesions ≥15 mm in shortest diameter on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound/CT/or endoscopic guidance.
• ECOG performance status of 0-1, with an estimated survival of at least 12 weeks.
• Sufficient organ and hematopoietic function.
• Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.
• Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for 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 those clinically stable for over 3 months following local treatment may be enrolled);
• Subjects who underwent radiotherapy to the target lesion within the past 2 months (may be enrolled if the radiotherapy site progressed);
• Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;
• Largest diameter of lesions for injection \>100 mm;
• Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;
• Subjects scheduled for or who have previously undergone tissue/organ transplantation;
• Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \< 350 cells/uL; Patients screening positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection, or screening positive for HCV antibody with HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;
• Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.
• Subjects requiring therapeutic anticoagulant therapy during the study period.
• Subjects with uncontrolled active infection ≥ Grade 3 according to CTCAE v5.0 that is clinically significant;
• Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to the first dose; Received nitrosourea or mitomycin C within 6 weeks prior to the first dose; Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to the first dose);

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Hebei, Langfang, China

Location

Study Officials

• Ning Li

  Chief, Office of Clinical Trial Center, CancerIHCAMS

  STUDY CHAIR

Central Study Contacts

Yanjie Han, MD

CONTACT

+86010-87788165; annyhan_1997@163.com

Shuhang Wang, MD

CONTACT

wangshuhang@cicams.ac.cn

Study Design

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

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)