Phase 2 Study Comparing the Safety and Efficacy of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with NSCLC or RCC

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmuneSensor Therapeutics Inc.
• Treatments: Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab

Criteria

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 NSCLC or RCC with radiographically documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of "oligometastatic" disease

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. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

7. Electrocardiogram (ECG) without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator

8. 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 aminotransferase (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

9. 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

10. Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study

Exclusion Criteria:

1. Prior receipt of programmed cell death ligand 1 (PD-L1 or PD-1)-targeted immunotherapy

2. Prior receipt of stimulator of interferon genes (STING) agonist

3. Prior receipt of therapeutic radiotherapy to the lesions intended for PULSAR treatment

4. Anti-cancer therapy within 4 weeks or < 5 half-lives of the first dose of study treatment

5. Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior anti-cancer therapy, as judged by the investigator

6. Existence of actionable mutations that may be eligible for mutation-targeted drug that represents standard-of-care therapy

7. Presence of brain metastases

8. Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval > 470)

9. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in the opinion of the investigator would limit compliance with study requirements

10. Women who are pregnant or breastfeeding

11. Sponsor reserves the right to exclude any patient from the study on the basis of pre-study medical histories, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria