Overview

Phase 2 Trial Comparing the Safety and Efficacy of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

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 oligoprogressive solid tumor malignancies after prior PD-L1or PD-1-targeted ICI immunotherapy
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 solid tumor malignancies demonstrating new
progression through prior PD-L1 or PD-1-targeted ICI, with a prior 3 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. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

7. Electrocardiogram (ECG) without evidence of clinically meaningful 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 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

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 stimulator of interferon genes (STING) agonist

2. Prior receipt of therapeutic radiotherapy to all progressive lesions intended for
PULSAR treatment

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

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

5. 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

6. Existence of actionable mutations that are eligible for a mutation-targeting drug that
represents standard-of-care

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

8. 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

9. Women who are pregnant or breastfeeding

10. 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