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.
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.
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;
Parallel
OVV-01
DrugOVV-01 is administered twice every two weeks
AK112
DrugAK112 is administered once every two weeks.
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.
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
ORR
The proportion of subjects achieving CR or PR will be assessed according to RECIST 1.1.
DCR
The proportion of subjects achieving CR, PR, or SD will be assessed according to RECIST 1.1.
DoR
Assessment will be conducted according to RECIST 1.1. For subjects achieving objective response, DOR is defined as the time from the first documented objective tumor response (CR or PR) to the first documented disease progression or death from any cause, whichever occurs first.
PFS
The time from the first study treatment to the first documented disease progression or death from any cause (whichever occurs first) will be assessed according to RECIST 1.1.
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