Trial Outcomes & Findings for Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies (NCT NCT05846659)
NCT ID: NCT05846659
Last Updated: 2026-05-15
Results Overview
Progression-free rate at 12 months
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
12 months
Results posted on
2026-05-15
Participant Flow
Study was terminated early by sponsor due to change in corporate strategy.
Participant milestones
| Measure |
Experimental Arm (800 mcg)
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
PULSAR-ICI
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
11
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
11
|
2
|
Reasons for withdrawal
| Measure |
Experimental Arm (800 mcg)
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
PULSAR-ICI
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
0
|
|
Overall Study
Early Study Termination
|
1
|
7
|
2
|
Baseline Characteristics
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies
Baseline characteristics by cohort
| Measure |
Experimental Arm (800 mcg)
n=3 Participants
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 Participants
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 Participants
PULSAR-ICI
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
8 Participants
n=186 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
8 Participants
n=186 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
7 Participants
n=186 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
9 Participants
n=186 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
13 Participants
n=186 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=186 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
13 Participants
n=186 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data were not collected due to study termination prior to participants' assessment at the 12-month time point
Progression-free rate at 12 months
Outcome measures
| Measure |
Experimental Arm (800 mcg)
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
PULSAR-ICI
|
|---|---|---|---|
|
Anti-tumor Effects
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 monthsOccurrence of treatment-related adverse events and SAEs
Outcome measures
| Measure |
Experimental Arm (800 mcg)
n=3 Participants
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 Participants
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 Participants
PULSAR-ICI
|
|---|---|---|---|
|
Safety and Tolerability
|
3 Participants
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 to 8 monthsPopulation: Only two patients made it to the 6-8 month treatment point at time study terminated early. Study terminated early, no analysis performed.
Progression-free at 8-week intervals from 6 months to 8 months.
Outcome measures
| Measure |
Experimental Arm (800 mcg)
n=2 Participants
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
PULSAR-ICI
|
|---|---|---|---|
|
Anti-tumor Effects
Progression Free
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anti-tumor Effects
Not evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: upon enrolment through end of study period (8 months)Population: 2 of 16 patients enrolled progressed at time study was terminated early. Since study terminated early, no analysis completed.
Time-to-progression (TTP)
Outcome measures
| Measure |
Experimental Arm (800 mcg)
n=3 Participants
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 Participants
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 Participants
PULSAR-ICI
|
|---|---|---|---|
|
Anti-tumor Effects
Progressed in 5 months
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anti-tumor Effects
Progressed in 4 months
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Anti-tumor Effects
Not evaluable
|
2 Participants
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: upon enrolment through end of study period (8 months)Population: Study terminated early, no analysis completed.
Overall response rate, duration of response, progression-free survival
Outcome measures
| Measure |
Experimental Arm (800 mcg)
n=3 Participants
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 Participants
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 Participants
PULSAR-ICI
|
|---|---|---|---|
|
Anti-tumor Effects
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-tumor Effects
Partial Response
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anti-tumor Effects
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-tumor Effects
Progressive Disease
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anti-tumor Effects
Not evaluable
|
1 Participants
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: upon enrolment through end of study period (8 months)Population: 16 patients completed a baseline questionnaire; 8 patients remained on trial long enough to complete a subsequent questionnaire
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
Outcome measures
| Measure |
Experimental Arm (800 mcg)
n=3 Participants
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 Participants
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 Participants
PULSAR-ICI
|
|---|---|---|---|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
Physical Well Being - Baseline
|
.95 Scores on a scale
Standard Deviation .85
|
.79 Scores on a scale
Standard Deviation .41
|
.71 Scores on a scale
Standard Deviation .95
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
Physical Well Being - post-Baseline
|
.98 Scores on a scale
Standard Deviation .43
|
1.08 Scores on a scale
Standard Deviation .44
|
—
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
SOCIAL/FAMILY WELL-BEING - Baseline
|
3.14 Scores on a scale
Standard Deviation 1.44
|
2.84 Scores on a scale
Standard Deviation 1.34
|
3.0 Scores on a scale
Standard Deviation 1.73
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
SOCIAL/FAMILY WELL-BEING - Post Baseline
|
2.96 Scores on a scale
Standard Deviation 1.23
|
2.81 Scores on a scale
Standard Deviation 1.31
|
—
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
EMOTIONAL WELL-BEING - Baseline
|
1.13 Scores on a scale
Standard Deviation 1.14
|
1.15 Scores on a scale
Standard Deviation 1.14
|
1.32 Scores on a scale
Standard Deviation .82
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
EMOTIONAL WELL-BEING - Post Baseline
|
1.10 Scores on a scale
Standard Deviation 1.01
|
1.27 Scores on a scale
Standard Deviation .79
|
—
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
FUNCTIONAL WELL-BEING - Baseline
|
2.88 Scores on a scale
Standard Deviation .44
|
2.87 Scores on a scale
Standard Deviation .21
|
3.29 Scores on a scale
Standard Deviation .76
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life (QoL)
FUNCTIONAL WELL-BEING - Post baseline
|
2.93 Scores on a scale
Standard Deviation .53
|
2.25 Scores on a scale
Standard Deviation .47
|
—
|
Adverse Events
Experimental Arm (800 mcg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Experimental Arm (1200 mcg)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm (800 mcg)
n=3 participants at risk
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 participants at risk
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 participants at risk
PULSAR-ICI
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Nervous system disorders
Cerebrovascular accident
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
Other adverse events
| Measure |
Experimental Arm (800 mcg)
n=3 participants at risk
PULSAR-ICI + IMSA101 (800 mcg)
|
Experimental Arm (1200 mcg)
n=11 participants at risk
PULSAR-ICI + IMSA101 (1200 mcg)
|
Control Arm
n=2 participants at risk
PULSAR-ICI
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
27.3%
3/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
54.5%
6/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
45.5%
5/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
General disorders
Chills
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
General disorders
Fatigue
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
36.4%
4/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
General disorders
Injection Site Reaction
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
36.4%
4/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
18.2%
2/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
50.0%
1/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
50.0%
1/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Investigations
Blood lactate dehydrogenase decreased
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
50.0%
1/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Investigations
Blood thyroid stimulating hormone
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
18.2%
2/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
18.2%
2/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Hypotension
|
33.3%
1/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
9.1%
1/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
18.2%
2/11 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
0.00%
0/2 • 8 months
Analysis population is the 16 patients enrolled to the trial.
|
Additional Information
Patrick Widhelm, Senior Director Clinical Operations and Project Management
ImmuneSensor Therapeutics, Inc.
Phone: 830-730-8176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place