Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT04787003
Brief Summary:
Phase Ia: To investigate the safety, tolerability and efficacy of OVV-01 injection in the treatment of patients with advanced solid tumors (OVV-01 single dose gradient exploration).
Phase Ib: To evaluate the safety, tolerability and efficacy of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in the treatment of patients with advanced solid tumors (OVV-01 combined with PD-1/PD-L1 monoclonal antibody dose gradient exploration);
Phase Ic: A cohort expansion of Phase Ib to further analyze the efficacy and safety of OVV-01 injection combined with immune checkpoint inhibitor injection in the treatment of advanced solid tumors.
Detailed Description:
Phase Ia:
This is a prospective, multicenter, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection in patients with advanced solid tumors.
This study plans to enroll in 1 \~ 3 study sites nationwide about 9 \~ 18 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ia study, i.e., the First in Human (FIH) trial of OVV-01 injection, using the traditional "3 + 3" approach for dose gradient exploration.
Phase Ib:
This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.
This study plans to enroll in 1 \~ 3 study sites nationwide about 12 \~ 24 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ib study, using the traditional "3 + 3" approach and based on the phase Ia results, 2 dose gradients of OVV-01 are used in combination with pembrolizumab and atezolizumab, respectively, to explore the efficacy and safety.
Phase Ic:
This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.
This study plans to enroll in 1 \~ 3 study sites nationwide about 15 \~ 20 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ic study.
Study:
NCT04787003
Study Brief:
Protocol Section:
NCT04787003