Open
Actively Recruiting
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies
About
Brief 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 oligoprogressive solid tumor malignancies after prior anti-cancer therapy.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Male or female patients ≥ 18 years of age
- Signed informed consent and mental capability to understand the informed consent
- 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
- Patient's disease must be evaluable per RECIST Version 1.1
- All metastatic lesions amenable to administration of radiotherapy, at the discretion of the investigator
- Must have at least one single pre-defined progressing lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Electrocardiogram (ECG) without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the investigator
- 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
- 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
- Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
Exclusion Criteria:
- Prior receipt of stimulator of interferon genes (STING) agonist
- Prior receipt of therapeutic radiotherapy to all progressive lesions intended for PULSAR treatment
- Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or < 5 half-lives of the first dose of study treatment
- Existence of primary tumor that requires therapeutic treatment beyond the provided immune checkpoint inhibitor drug
- Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior anti-cancer therapy, as judged by the investigator
- Previous life-threatening (Grade 4) immune-related adverse event (irAE)
- Known untreated brain metastases or treated brain metastases that have not been stable (scan showing no worsening of central nervous system [CNS] lesion[s] and no requirement of corticosteroids) ≥ 4 weeks prior to study enrollment
- Existence of actionable mutations that are eligible for a mutation-targeting drug that represents standard-of-care
- Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval > 470)
- 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
- Women who are pregnant or breastfeeding
- 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
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Study Stats
Protocol No.
23-001020
Category
Other Cancer
Principal Investigator
Contact
Location
- UCLA Westwood