Study of PULSAR-ICI +/- IMSA101 in Patients with Oligoprogressive Solid Tumor Malignancies
NCT ID: NCT05846659
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2023-07-07
2024-11-20
Brief Summary
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Detailed Description
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1. 15 patients in the control arm (PULSAR-ICI alone)
2. 30 patients in the experimental arm (PULSAR-ICI + IMSA101)
PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.
The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.
All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.
All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).
Tumor types and the corresponding treatment combinations to be evaluated will be identified prior to the first patient enrolled.
All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm
PULSAR-ICI + IMSA101
IMSA101
Intra-tumoral administration once weekly for the first three weeks of Cycle 1 (Days 1, 8 and 15) and then on Day 1 of Cycles 2 and 3.
Immune checkpoint inhibitor
1st infusion on Cycle 1 Day 2, and then thereafter as per product label.
PULSAR
1st day of Cycles 1, 2 and 3.
Control Arm
PULSAR-ICI
Immune checkpoint inhibitor
1st infusion on Cycle 1 Day 2, and then thereafter as per product label.
PULSAR
1st day of Cycles 1, 2 and 3.
Interventions
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IMSA101
Intra-tumoral administration once weekly for the first three weeks of Cycle 1 (Days 1, 8 and 15) and then on Day 1 of Cycles 2 and 3.
Immune checkpoint inhibitor
1st infusion on Cycle 1 Day 2, and then thereafter as per product label.
PULSAR
1st day of Cycles 1, 2 and 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Prior receipt of therapeutic radiotherapy to all progressive lesions intended for PULSAR treatment
3. Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or \< 5 half-lives of the first dose of study treatment
4. Existence of primary tumor that requires therapeutic treatment beyond the provided immune checkpoint inhibitor drug
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. Previous life-threatening (Grade 4) immune-related adverse event (irAE)
7. 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
8. Existence of actionable mutations that are eligible for a mutation-targeting drug that represents standard-of-care
9. Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval \> 470)
10. 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
11. Women who are pregnant or breastfeeding
12. 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
18 Years
ALL
No
Sponsors
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ImmuneSensor Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Widhelm
Role: STUDY_DIRECTOR
ImmuneSensor Therapeutics
Locations
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City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Brigham and Women's Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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IMSA101-103
Identifier Type: -
Identifier Source: org_study_id