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Nivolumab

Intravenous with or without Intratumoral RT-01 in the treatment of patients with advanced solid tumors combined with or without Nivolumab in the treatment of patients with advanced solid tumors

Intravenous injection of RT-01 with or without Nivolumab

Oncolytic Virus Injection (RT-01）

Peihua Lu, MD

This is a single-arm, open-lable study to determine the safety, tolerability and preliminary efficacy of oncolytic virus injection (RT-01) combined with or without immune checkpoint inhibitors (Nivolumab) in the treatment of patients with advanced solid tumors.

To evaluate the safety, tolerability, efficacy, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01 injection given via Intravenous with or without Intratumoral administration combined with immune checkpoint inhibitors Nivolumab in the treatment of patients with advanced solid tumors.

RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors

An Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravenous With and Without Intratumoral Oncolytic Virus Injection (RT-01) Combined With or Without Immune Checkpoint Inhibitors (Nivolumab) in the Treatment of Patients With Advanced Solid Tumors

Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Defined as the highest safety-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.

Graded according to the NCI CTCAE version 5.0.

Proportion of patients in the analysis population who have complete response (CR) or partial response (PR) based on RECIST v1.1 imaging.

Proportion of patients in the analysis population who have complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 imaging.

Survival time is defined as the time from registration to death due to any cause.

Progression-free survival is defined as the time from registration to the earliest date documentation of disease progression or death due to any cause.

Assessed via quantitative reverse transcriptase polymerase chain reaction.

Wuxi People's Hospital

Oncolytic virus (OVV-01) injection combined with or without immune checkpoint inhibitors in the treatment of patients with advanced solid tumors.

intratumoral injection of OVV-01 with or without immune checkpoint inhibitors

oncolytic virus (OVV-01) injection

Yan-hua Bi, M.D

QIANG LIN, Dr

Qiang Lin, Ph.D

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.

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.

Oncolytic Virus (OVV-01) Injection in the Treatment of Patients With Advanced Solid Tumors

A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Oncolytic Virus (OVV-01) Injection Combined With or Without Immune Checkpoint Inhibitors in the Treatment of Patients With Advanced Solid Tumors

After the publication of this study, we could share the IPD. However, this sharing is limited to academic research.

Person to be contacted: Study Chair-Professor Qiang Lin; Contact information:billhappy001@163.com

to define the maximum tolerated dose (MTD) of intratumoral administration of OVV-01 injection in humans with malignant tumors.

to evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in patients with advanced solid tumors.

to evaluate preliminary efficacy assessed by the RECISTv1.1 of intratumoral administration of OVV-01 injection in the treatment of patients with advanced solid tumors

to evaluate the preliminary efficacy assessed by the RECISTv1.1 of intratumoral administration of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in patients with advanced solid tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors	NCT05122572	Advanced Solid ...	Oncolytic Virus...	18 Years -	Wuxi People's Hospital
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors	NCT05122572	Advanced Solid ...	Oncolytic Virus...	18 Years -	Wuxi People's Hospital
Oncolytic Virus (OVV-01) Injection in the Treatment of Patients With Advanced Solid Tumors	NCT04787003	Neoplasms	oncolytic virus...	18 Years - 70 Years	North China Petroleum Bureau General Hospital
Oncolytic Virus (OVV-01) Injection in the Treatment of Patients With Advanced Solid Tumors	NCT04787003	Neoplasms	oncolytic virus...	18 Years - 70 Years	North China Petroleum Bureau General Hospital

Spots Global Cancer Trial Database for oncolytic virus injection