Study of PULSAR-ICI +/- IMSA101 in Patients with Oligoprogressive Solid Tumor Malignancies

Inclusion Criteria

• •1. Male or female patients ≥ 18 years of age
• •2. Signed informed consent and mental capability to understand the informed consent
• •3. Histologically or cytologically documented solid tumor malignancies demonstrating new progression through prior anti-cancer therapy, with a prior 2 months of clinical stability (with at least Stable Disease), with radiographically documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of "oligoprogressive" disease that are technically amenable to PULSAR
• •4. Patient's disease must be evaluable per RECIST Version 1.1
• •5. All metastatic lesions amenable to administration of radiotherapy, at the discretion of the investigator
• •6. Must have at least one single pre-defined progressing lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection
• •7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• •8. Electrocardiogram (ECG) without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the investigator
• •9. Acceptable organ and marrow function as defined below:
• •* Absolute neutrophil count (ANC) \> 1,500 cells/μL
• •* Platelets \> 50,000 cells/μL
• •* Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN)
• •* Aspartate aminotransferase (AST)/alanine aminotransaminase (ALT) ≤ 2.5 × ULN. If liver metastases are present, AST/ALT \< 5 × ULN
• •* Serum creatinine \< 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
• •* Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN
• •10. Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization \[hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test prior to first dose of study treatment
• •11. Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study