OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced S… (NCT07650825) | Clinical Trial Compass
Not Yet RecruitingPhase 1
OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors
China30 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DLT
Timeframe: Within 21 days after administration
2
Incidence of Adverse Events (AEs)
Timeframe: From signing ICF until 24 months after the last infusion.
Trial details
NCT IDNCT07650825
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. 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.
Exclusion criteria
. 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.