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1.Only 1 lesion: If the tumor volume is less than or equal to 10 cm3, the whole tumor is injected radially and evenly.

If the tumor volume was \>10 cm3, the tumor was evenly divided into five quadrants and injected into one quadrant at a time.

2. If there are 2 or more lesions, the most manageable tumor injection is selected; 3. Priority should be given to the body surface metastases that meet the evaluation criteria for tumor efficacy.

4. According to patients' conditions (e.g., patients with thorax and ascites), the investigator and the research group and cooperative units jointly explored other drug administration approaches (e.g., bladder infusion, thorax and abdominal cavity administration)

Before use, dilute the product with normal saline according to the size of the tumor to an appropriate volume (10-30% of the total volume of the tumor), or adjust appropriately according to the specific tumor situation, inject directly into the tumor or inject under the guidance of B ultrasound /CT, inject the drug solution into the tumor edge and tumor evenly

Recombinant L-IFN adenovirus injection

Rong Zhang, MD

Feng Liu, PhD

This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-01） when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection

This is an investigator initiated , open-label, study of Recombinant oncolytic adenovirus L-IFN injection given via intratumoral (IT) injection as a single agent in participants with advanced solid tumors. The study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of Recombinant L-IFN adenovirus injection. Total enrollment will depend on the toxicities and/or activity observed, with approximately19-28 evaluable participants enrolled.

The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of Recombinant oncolytic adenovirus L-IFN injection as a single agent. Secondary objectives will assess efficacy overall response rate, as well as disease control rate, progression free survival, duration of response, and anti-tumor immune responses.

Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study

Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study

To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors.

An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP

Number of participants with potentially clinically significant laboratory values

To evaluate the immunogenicity of Recombinant L-IFN adenovirus injection given as single agent post injection

Shanghai Yuansong Biotechnology Co., LTD

Shanghai Fengxian District Central Hospital

Spots Global Cancer Trial Database for replicative adenovirus