Soft Tissue Cancer

The purpose of this research is to study the safety and effectiveness of investigational antibodies attacking certain areas on the surface of cancer cells so that the body can kill the cancer cells. The antibodies will be made in a laboratory from cells taken from each subject's tumor so they will be made specifically per subject. The first step is to take blood and tumor samples so that the laboratory can produce antibodies specific to each subject's tumor. During this process, the study team will identify specific areas on the cancer cells that are not normally present in healthy cells so that the antibodies can find the cancer cells that should be destroyed. The second step is to deliver the antibodies to each subject through a series of infusions.

Study Primary Objective: To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors. Study Secondary Objectives: 1. To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy at both injected and non-injected lesions; 2. To evaluate the safety and tolerability of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors; 3. To evaluate the pharmacokinetic (PK) characteristics of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors. Study Population: Patients with histologically or cytologically confirmed solid tumors including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., who are assessed by the investigator as suitable for standard radiotherapy including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients not suitable for surgery (Cohort A2) Study Drug Administration Schedule: Single administration, 2 weeks per administration cycle, total 1-4 cycles Study Primary Endpoint: Objective Response Rate (ORR) assessed according to RECIST 1.1 criteria Study Key Secondary Endpoints: 1. Patients with unresectable locally advanced or advanced solid tumors: Local Control Rate (LCR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP), Time to Response (TTR), and Overall Survival (OS); 2. Patients receiving preoperative neoadjuvant therapy: Major Pathological Response (MPR), Disease-Free Survival (DFS), Disease Control Rate (DCR);