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

NCT05846659 | Terminated Phase 2 FDA Drug

• 1 other identifier: IMSA101-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 14

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.

Conditions

Oligoprogressive

Keywords

Oligoprogressive solid tumor malignancies; Adult

Outcome Measures

Primary Outcomes (1)

• Anti-tumor effects

  Progression-free rate at 12 months

  assessment at 12 months

Secondary Outcomes (5)

• Safety and tolerability

  upon enrolment through end of study period (2 years)

• Anti-tumor effects

  6 to 22 months

• Anti-tumor effects

  upon enrolment through end of study period (2 years)

• Anti-tumor effects

  upon enrolment through end of study period (2 years)

• Quality of life (QoL)

  upon enrolment through end of study period (2 years)

Study Arms (2)

Experimental Arm

EXPERIMENTAL

PULSAR-ICI + IMSA101

Drug: IMSA101; Drug: Immune checkpoint inhibitor; Radiation: PULSAR

Control Arm

ACTIVE COMPARATOR

PULSAR-ICI

Drug: Immune checkpoint inhibitor; Radiation: PULSAR

Interventions

IMSA101 DRUG

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.

Experimental Arm

Immune checkpoint inhibitor DRUG

1st infusion on Cycle 1 Day 2, and then thereafter as per product label.

Also known as: pembrolizumab, nivolumab

Control Arm; Experimental Arm

PULSAR RADIATION

1st day of Cycles 1, 2 and 3.

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneSensor Therapeutics Inc.: lead

Study Sites (14)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Brigham and Women's Hospital/Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; pembrolizumab; Nivolumab; DEAE-Dextran

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Patrick Widhelm

  ImmuneSensor Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: July 7, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)