The efficacy of OVV-01 injection in combination with AK112 injection in subjects with advanced soft tissue sarcoma was evaluated using ORR as the primary endpoint.
Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures;
Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.
Histologically/cytologically confirmed metastatic or recurrent unresectable soft tissue sarcoma, currently failing standard therapy (disease progression, recurrence, or intolerance to treatments such as chemotherapy, radiotherapy, or targeted therapy) or lacking standard treatment options. Participants must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies). Subjects must have demonstrated failure or intolerance to anthracycline-based standard chemotherapy regimens. For specific histologic subtypes lacking standard effective chemotherapy options (e.g., alveolar soft part sarcoma), subjects may have previously received targeted therapy (e.g., anti-angiogenic agents such as anlotinib, pazopanib) with failure or intolerance.
Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions with a longest diameter ≥10 mm and lymph node lesions with a shortest diameter ≥15 mm 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 received radiotherapy to the target lesion within the past 2 months;
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;
Lesions intended for injection with a maximum diameter >100 mm;
Single group
OVV-01，AK112
DrugAdminister once every two weeks.
ORR
Overall response rate assessed per RECIST 1.1
Duration of Response (DOR)
The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death from any cause.
Progression-Free Survival (PFS)
The time from the first dose of study drug until the first documentation of objective tumor progression or death from any cause.
Overall Survival (OS)
The time from the first dose of study drug to death from any cause.
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
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