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OligoprogressivePhase 2NCT05846659

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

A Phase 2 study testing IMSA101, Immune checkpoint inhibitor and PULSAR in people with Oligoprogressive, run by ImmuneSensor Therapeutics Inc. at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oligoprogressive
What is being tested?
IMSA101, Immune checkpoint inhibitor and PULSAR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
14 sitesUnited States
Study dates
7 Jul 2023to 20 Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Brigham and Women's Hospital/Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA

    Los Angeles, California, 90095

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

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.

Read the detailed description

Patients shall be enrolled in 2 treatment arms as follows:

  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.

Being tested
IMSA101, Immune checkpoint inhibitor, PULSAR
Keywords
Oligoprogressive solid tumor malignancies, Adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMSA101Drug

    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 inhibitorDrug

    Also called pembrolizumab, nivolumab

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

  • PULSARRadiation

    1st day of Cycles 1, 2 and 3.

Study groups in NCT05846659
Study groupRoleWhat they receive
Experimental ArmExperimentalPULSAR-ICI + IMSA101
Receives: Drug: IMSA101; Drug: Immune checkpoint inhibitor; Radiation: PULSAR
Control ArmActive comparatorPULSAR-ICI
Receives: Drug: Immune checkpoint inhibitor; Radiation: PULSAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-tumor Effects

    Progression-free rate at 12 months

    Measured: 12 months

Secondary outcomes (5)

  1. Safety and Tolerability

    Occurrence of treatment-related adverse events and SAEs

    Measured: 8 months

  2. Anti-tumor Effects

    Progression-free at 8-week intervals from 6 months to 8 months.

    Measured: 6 to 8 months

  3. Anti-tumor Effects

    Time-to-progression (TTP)

    Measured: upon enrolment through end of study period (8 months)

  4. Anti-tumor Effects

    Overall response rate, duration of response, progression-free survival

    Measured: upon enrolment through end of study period (8 months)

  5. Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)

    The Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported outcome (PRO) assessing health-related quality of life (HRQoL) in individuals with cancer across physical, social/family, emotional, and functional domains.

    The FACT-G (Version 4) contains 27 items across four subscales. Each item uses a 0-4 Likert scale (0 = Not at all, 4 = Very much), with some items reverse-scored so that higher scores always indicate better quality of life.

    Physical Well-Being (PWB) - 7 items, score range 0-28 (higher = better physical well-being.

    Social/Family Well-Being (SWB) - 7 items, score range 0-28 (higher = better social/family well being) Emotional Well-Being (EWB) - 6 items, score range 0-24 (higher = better emotional well-being) Functional Well-Being (FWB) - 7 items, score range 0-28 (higher = better functional well being)

    Scores provided show average baseline and average post-baseline comparison scores for all patient who completed the FACT-G questionnaire on trial

    Measured: upon enrolment through end of study period (8 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start7 Jul 2023
  3. Primary completion20 Nov 2024
  4. Study completion20 Nov 2024

Why it stopped: Change in ImmuneSensor corporate strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846659
Sponsor's protocol ID
IMSA101-103
Status last verified
May 2026
First submitted
27 Apr 2023
Last updated
15 May 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMSA101, Immune checkpoint inhibitor and PULSAR in people with Oligoprogressive, run by ImmuneSensor Therapeutics Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-tumor Effects (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05846659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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