This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (NCT04853017), a non-randomized phase 1 study. The primary outcome is The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04853017 |
| Phase | Phase 1 |
| Condition | Minimal Residual Disease, KRAS G12D, KRAS G12R |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Elicio Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
Participants had minimal residual disease following treatment for KRAS- or NRAS-mutated pancreatic ductal adenocarcinoma or other solid tumors. The registry lists pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, ovarian cancer, cholangiocarcinoma, bile duct cancer and gallbladder carcinoma among the conditions. The primary safety analysis population was all enrolled subjects.
Intervention
ELI-002 2P, a combination of Amph-CpG-7909 and Amph-modified peptide antigens. The five cohorts received different stated amounts of Amph-CpG-7909: 0.1 mg, 0.5 mg, 2.5 mg, 5.0 mg or 10.0 mg. The registry describes subcutaneous administration and an immunization schedule, but the cohort descriptions are truncated before the full schedules are given.
Comparator
There was no randomized control group. This was a nonrandomized, sequential Phase 1 study with five ELI-002 2P cohorts, so comparisons between cohorts are not like-for-like comparisons against a control intervention. Differences between cohort counts cannot isolate a treatment effect from differences in cohort membership or other factors.
Primary question
How many participants experienced treatment-emergent adverse events that the investigator considered related to ELI-002? Events were collected through 28 days after the last dose. The registry also lists biomarker reduction and clearance as secondary outcome topics, but the posted record does not give their results in the registry record described for this analysis.
3. Trial Design
This was a first-in-human Phase 1 trial of ELI-002, an immunotherapy being studied as adjuvant treatment for minimal residual disease in people with KRAS- or NRAS-mutated pancreatic ductal adenocarcinoma or other solid tumors. The registry lists the allocation as nonrandomized, the model as sequential and masking as none. Enrollment was 25. The sponsor was Elicio Therapeutics, and the record marks the study completed.
Participants were placed in five ELI-002 2P cohorts. Each cohort description specifies a different amount of Amph-CpG-7909, from 0.1 mg in Cohort 1 to 10.0 mg in Cohort 5, combined with Amph-modified KRAS peptides. The descriptions state subcutaneous administration and describe an initial weekly immunization period followed by additional injections. Because the posted cohort descriptions end mid-sentence, the complete schedules cannot be established from this record.
The study started on 2021-10-04, with primary completion on 2023-01-26. The primary outcome was the participant incidence of treatment-emergent adverse events considered by the investigator to be related to ELI-002. The stated collection period extended through 28 days after the last dose, and the analysis population was all enrolled subjects.
Other listed outcomes concern the proportion of participants with biomarker reduction or clearance, including breakdowns by biomarker type. The record does not describe a randomized comparator, blinding, or a concurrent control arm. Consequently, the cohort observations are descriptive safety information from a sequential dose study, not a randomized estimate of the difference between ELI-002 and another treatment or no treatment.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | ELI-002 2P Cohort 1 | ELI-002 2P Cohort 2 | ELI-002 2P Cohort 3 | ELI-002 2P Cohort 4 | ELI-002 2P Cohort 5 |
|---|---|---|---|---|---|
| STARTED | 3 | 6 | 5 | 5 | 6 |
| COMPLETED | 1 | 2 | 2 | 3 | 3 |
| NOT COMPLETED | 2 | 4 | 3 | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: All enrolled subjects were included in the analysis.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | ELI-002 2P Cohort 1 | ELI-002 2P Cohort 2 | ELI-002 2P Cohort 3 | ELI-002 2P Cohort 4 | ELI-002 2P Cohort 5 | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 6 | 5 | 5 | 6 | 25 | |
| Age, Continuous | years | 50.0 (47 to 61) | 54.5 (37 to 69) | 67.0 (63 to 77) | 67.0 (47 to 75) | 59.0 (48 to 69) | 61.0 (37 to 77) |
| Sex: Female, Male: Female | Participants | 2 | 5 | 4 | 3 | 1 | 15 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 1 | 2 | 5 | 10 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 5 | 4 | 5 | 5 | 21 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 | 0 | 0 | 2 |
| Region of Enrollment: United States | participants | 3 | 6 | 5 | 5 | 6 | 25 |
| Pancreatic ductal adenocarcinoma diagnosis | Participants | 1 | 4 | 5 | 4 | 6 | 20 |
| Disease stage at screening: Stage I, II | Participants | 1 | 2 | 3 | 1 | 1 | 8 |
| Disease stage at screening: Stage III, IV | Participants | 2 | 4 | 2 | 4 | 5 | 17 |
6. Primary Endpoint
The registry lists the primary outcome as The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002, measured over Adverse events were collected through 28 days after the last dose.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants who experienced at least one treatment-emergent adverse event that the investigator considered related to ELI-002. It is a participant-level count, rather than a count of all event episodes: a participant with multiple events still contributes as one participant to this type of incidence measure. The registry states that all enrolled subjects were included in the analysis and that adverse events were collected through 28 days after the last dose.
In an early-phase study, systematic safety monitoring is important because the intervention is being evaluated in a first-in-human setting. A participant-incidence measure offers a direct description of how many people had events judged related to treatment during the stated observation period. It does not, by itself, describe event duration, severity, recurrence, or the total number of event episodes. Those details require separate reporting.
The distinction between an event occurring after treatment and an event judged related to treatment matters. The primary endpoint specifically concerns the investigator’s assessment of relatedness. The posted cohort counts for serious and other adverse events are not identified as the primary endpoint counts, so they should not be substituted for the primary result. A numerical result for the primary endpoint is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a small, nonrandomized, sequential study organized into five dose cohorts. The enrollment was 25, and the serious-adverse-event counts list 3 participants at risk in Cohort 1, 6 in Cohort 2, 5 in Cohort 3, 5 in Cohort 4 and 6 in Cohort 5. The corresponding numbers with serious adverse events were 1, 0, 0, 0 and 1. The counts for participants with other adverse events were 3, 5, 4, 4 and 5, respectively. No deaths are listed in any cohort.
These counts give a descriptive account of the recorded events in each cohort. They do not establish that the dose levels caused differences in event occurrence. Cohort assignment was not randomized, and there was no like-for-like control group. The number of participants in each cohort is limited, so the observed counts provide only a coarse picture of how often events occurred in this study. They should not be treated as precise estimates of event frequency in a broader population.
The serious-event counts are not interchangeable with the primary endpoint. The primary outcome is restricted to treatment-emergent events considered related to ELI-002 by the investigator. The cohort-level serious-event figures do not state that all those events were considered related, and the other-adverse-event figures do not provide that relatedness information either. The record separately lists Abdominal wall haematoma at 33.3% and Nephrolithiasis at 16.7% among the top serious terms. These term frequencies are descriptive registry entries; the record does not provide enough detail to assign them to a particular cohort or infer a causal relationship.
The primary outcome’s numerical result, uncertainty interval and inferential analysis are not reported in the registry record. The number of posted analyses is 0. Therefore, there is no reported p-value or confidence interval to use when judging statistical precision. The record does not permit a formal comparison among dose cohorts or a conclusion about differences against an untreated or alternative-treatment group. The posted data support a description of observed event counts in this trial, not an estimate of comparative safety or efficacy.
The study also lists biomarker reduction and clearance outcomes, including analyses by biomarker type, but their results are not reported in the registry record. Any interpretation of the study’s biological or clinical outcomes must therefore remain separate from the available adverse-event counts. In particular, the presence of secondary outcome titles does not reveal how many participants met those outcomes or how precisely any such proportion was estimated.
9. Statistical Methods Explained
What does a participant count mean?
The primary outcome is a binary participant-level measure: each enrolled participant either had at least one treatment-emergent adverse event judged related to ELI-002 during the specified collection period or did not. A count of participants with an event is different from a count of event episodes. For example, several events in one participant do not necessarily represent several participants. This type of endpoint can be summarized by the number with an event and the number assessed, with a proportion often used to describe incidence. The record identifies the endpoint as a participant count, but a numerical primary-endpoint result is not reported in the registry record.
Why do the cohort counts need context?
Each cohort has a small number of participants at risk, and the study was nonrandomized and sequential. In general, random allocation helps balance measured and unmeasured participant characteristics across comparison groups. Without random allocation, cohort differences may reflect who entered each cohort, the sequence in which cohorts were enrolled, or other factors as well as the intervention amount. A control group also gives a direct reference for the outcome under a different treatment condition. Neither a randomized comparison nor a control arm is described in this record.
In general, a confidence interval expresses the uncertainty around an estimated quantity, such as a participant-event proportion. A narrower interval indicates greater precision under the assumptions of the method; a wider interval indicates less precision. With small groups, estimates can be particularly uncertain. No confidence interval for the primary outcome is reported in the registry record, so its statistical precision cannot be quantified from the posted primary result.
What can a hypothesis test tell us?
In general, a hypothesis test evaluates whether observed data are compatible with a specified null model, under assumptions about the design and analysis. A p-value is not the probability that a treatment works, nor does it measure the size or importance of an effect. It also cannot repair confounding in a nonrandomized comparison. No inferential analyses are listed in the registry record, and no p-value for the primary outcome is reported. The cohort counts should therefore be read descriptively, rather than as evidence from a formal statistical test of cohort differences.
What is over-dispersion?
In general, over-dispersion occurs when observed variation in counts is greater than a statistical model expects. It can make standard errors too small and confidence intervals too narrow if the model assumes less variability than the data contain. This concern most often arises in count models where event counts vary across participants or settings. The primary outcome in this study is described as a count of participants with an event, not a repeated-event count model, and no model-based analysis or dispersion estimate is reported in the registry record. Over-dispersion cannot be assessed from the posted information.
How should the planning illustrations be understood?
The statistical planning illustrations are based on the observed effect rather than the trial’s own design. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and detection of a stated fraction of the observed effect. For time-to-event outcomes, the illustrations concern the total number of events; for other outcomes, they concern participants per arm. These are hypothetical planning quantities, not observed trial results and not evidence that the study had a particular probability of detecting an effect. The registry record does not report that these assumptions were used to plan this trial, and no sample-size justification for the trial is reported.
What does the registry say about analysis populations?
For the primary safety outcome, the analysis population is stated as all enrolled subjects. That describes who was intended to be included, but it does not explain how missing event information, withdrawal, incomplete follow-up or other unavailable observations were handled. Those details are not reported in the registry record. The posted serious and other adverse-event counts provide cohort-specific denominators, but they do not supply a complete account of follow-up for every outcome.
Overall, the statistical information supports reading the adverse-event figures as descriptive counts. The record does not provide an inferential analysis, uncertainty intervals, or enough methodological detail to reproduce or assess a model-based estimate. General statistical concepts can clarify what such analyses would mean, but they cannot supply results absent from the registry.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| ELI-002 2P Cohort 1 | 3 | 1 | 33.3% | 0.8% to 90.6% | 6.1% to 79.2% | 6.8% to 80.6% |
| ELI-002 2P Cohort 2 | 6 | 3 | 50.0% | 11.8% to 88.2% | 18.8% to 81.2% | 18.4% to 81.6% |
| ELI-002 2P Cohort 3 | 5 | 2 | 40.0% | 5.3% to 85.3% | 11.8% to 76.9% | 11.8% to 77.7% |
| ELI-002 2P Cohort 4 | 5 | 2 | 40.0% | 5.3% to 85.3% | 11.8% to 76.9% | 11.8% to 77.7% |
| ELI-002 2P Cohort 5 | 6 | 4 | 66.7% | 22.3% to 95.7% | 30.0% to 90.3% | 29.0% to 90.1% |
R code and output
arm <- c("ELI-002 2P Cohort 1", "ELI-002 2P Cohort 2", "ELI-002 2P Cohort 3", "ELI-002 2P Cohort 4", "ELI-002 2P Cohort 5")
n <- c(3, 6, 5, 5, 6)
events <- c(1, 3, 2, 2, 4)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM ELI-002 2P Cohort 1 3 1 33.3 0.8 90.6 6.1 79.2 6.8 80.6
ARM ELI-002 2P Cohort 2 6 3 50.0 11.8 88.2 18.8 81.2 18.4 81.6
ARM ELI-002 2P Cohort 3 5 2 40.0 5.3 85.3 11.8 76.9 11.8 77.7
ARM ELI-002 2P Cohort 4 5 2 40.0 5.3 85.3 11.8 76.9 11.8 77.7
ARM ELI-002 2P Cohort 5 6 4 66.7 22.3 95.7 30.0 90.3 29.0 90.111. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes: biomarker reduction, biomarker clearance, and each outcome by biomarker type. Multiple outcomes create a general multiplicity issue because examining many outcomes can increase the chance of at least one apparently notable result by chance. Statistical approaches can address that issue, but the appropriate approach depends on the prespecified questions and analysis plan. A multiplicity adjustment or hierarchy among outcomes is not reported in the registry record. No results or analyses for the listed biomarker outcomes are reported in the registry record.
Missing-data handling is also not described. The primary safety analysis population is stated as all enrolled subjects, but the record does not explain how incomplete follow-up, withdrawal, missing event assessments, or unavailable biomarker measurements were handled. It does not report an imputation method or a sensitivity analysis for missing observations. The intended population alone does not establish that every participant had complete outcome information.
The analysis information is limited: the number of listed analyses is 0. A statistical analysis plan, interim analysis plan, and methods for controlling type I error are not reported in the registry record. Those methods should not be inferred from the Phase 1 designation or from the presence of several outcome titles. Without reported analyses and missing-data procedures, the posted outcome counts can be described, but the robustness of any broader inference cannot be evaluated.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| ELI-002 2P Cohort 1 | 1 | 3 | 33.3% |
| ELI-002 2P Cohort 2 | 0 | 6 | 0.0% |
| ELI-002 2P Cohort 3 | 0 | 5 | 0.0% |
| ELI-002 2P Cohort 4 | 0 | 5 | 0.0% |
| ELI-002 2P Cohort 5 | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ELI-002 2P Cohort 1 | 0 of 3 |
| ELI-002 2P Cohort 2 | 0 of 6 |
| ELI-002 2P Cohort 3 | 0 of 5 |
| ELI-002 2P Cohort 4 | 0 of 5 |
| ELI-002 2P Cohort 5 | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| ELI-002 2P Cohort 1 | 3 of 3 |
| ELI-002 2P Cohort 2 | 5 of 6 |
| ELI-002 2P Cohort 3 | 4 of 5 |
| ELI-002 2P Cohort 4 | 4 of 5 |
| ELI-002 2P Cohort 5 | 5 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | ELI-002 2P Cohort 1 | ELI-002 2P Cohort 2 | ELI-002 2P Cohort 3 | ELI-002 2P Cohort 4 | ELI-002 2P Cohort 5 |
|---|---|---|---|---|---|---|
| Abdominal wall haematoma | Gastrointestinal disorders | 1 of 3 | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 6 |
| Nephrolithiasis | Renal and urinary disorders | 0 of 3 | 0 of 6 | 0 of 5 | 0 of 5 | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ELI-002 2P Cohort 1 | ELI-002 2P Cohort 2 | ELI-002 2P Cohort 3 | ELI-002 2P Cohort 4 | ELI-002 2P Cohort 5 |
|---|---|---|---|---|---|---|
| Fatigue | General disorders | 1 of 3 | 2 of 6 | 2 of 5 | 1 of 5 | 1 of 6 |
| Hyperglycaemai | Metabolism and nutrition disorders | 0 of 3 | 0 of 6 | 2 of 5 | 2 of 5 | 2 of 6 |
| Abdominal pain | Gastrointestinal disorders | 1 of 3 | 1 of 6 | 0 of 5 | 0 of 5 | 2 of 6 |
| Headache | Nervous system disorders | 2 of 3 | 1 of 6 | 0 of 5 | 0 of 5 | 1 of 6 |
| Anaemia | Blood and lymphatic system disorders | 2 of 3 | 0 of 6 | 1 of 5 | 0 of 5 | 0 of 6 |
| Diarrhoea | Gastrointestinal disorders | 0 of 3 | 1 of 6 | 1 of 5 | 0 of 5 | 1 of 6 |
| Malaise | General disorders | 1 of 3 | 1 of 6 | 0 of 5 | 0 of 5 | 1 of 6 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 3 | 1 of 6 | 1 of 5 | 0 of 5 | 1 of 6 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0 of 3 | 0 of 6 | 0 of 5 | 1 of 5 | 2 of 6 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 1 of 6 | 0 of 5 | 2 of 5 | 0 of 6 |
Serious events with the highest arm-level rate: abdominal wall haematoma (33.3%), nephrolithiasis (16.7%).
The serious adverse-event counts are reported by cohort. Cohort 1 lists 3 participants at risk and 1 with a serious adverse event; Cohort 2 lists 6 at risk and 0 affected; Cohort 3 lists 5 and 0; Cohort 4 lists 5 and 0; and Cohort 5 lists 6 and 1. The listed death count is 0 for each cohort. For other adverse events, the counts at risk and affected are 3 and 3 in Cohort 1, 6 and 5 in Cohort 2, 5 and 4 in Cohort 3, 5 and 4 in Cohort 4, and 6 and 5 in Cohort 5.
The registry also lists Abdominal wall haematoma at 33.3% and Nephrolithiasis at 16.7% among the top serious adverse-event terms. These are term frequencies in the record, not a complete account of event severity, duration, recurrence or relatedness. The record does not identify those terms by cohort in the registry record.
These are descriptive figures from small, nonrandomized cohorts. They are not the primary endpoint result unless the events were also treatment-emergent and judged related by the investigator; that connection is not specified in the cohort figures. Counts alone do not establish causation, and they are not a basis for comparing safety against a control group, since no randomized control group is described.
13. What the Result Does, and Does Not, Mean
The results mean that the registry records serious and other adverse-event counts across five sequential ELI-002 2P cohorts, along with a zero death count in each cohort. The primary endpoint is defined as the number of participants with treatment-emergent adverse events considered related to ELI-002 by the investigator, collected through 28 days after the last dose. However, a numerical result for that endpoint is not reported in the registry record. The cohort-level serious and other event counts are not explicitly identified as investigator-related primary endpoint results.
The figures do not establish how ELI-002 compares with another treatment, no treatment, or usual care. There is no randomized comparator, and the allocation is nonrandomized and sequential. Nor do the counts establish that a difference between cohorts was caused by the different amounts of Amph-CpG-7909. Cohort size and participant characteristics can vary, and the posted information does not describe adjustment for such differences.
The record does not establish efficacy from the safety counts. Although biomarker reduction and clearance are listed as secondary outcomes, their numerical results are not reported in the registry record. No inferential analyses or confidence intervals are listed for the outcomes described in the registry record. Accordingly, the statistical precision of the primary result and the biomarker outcomes cannot be assessed from this information.
The findings are best understood as an early-phase descriptive record of events among enrolled participants, within the stated event-collection period and cohort structure. They provide context about what was recorded during the study, but do not determine the frequency of events in other populations or settings. They also do not resolve questions that require a control group, complete outcome reporting, or a prespecified comparative analysis.
14. Why This Trial Matters Statistically
Early-phase trials often prioritize structured observation of safety while an intervention is being studied in people for the first time. This trial’s primary question is framed at the participant level: how many participants had treatment-emergent events considered related to ELI-002? That focus makes the distinction between event occurrence, event severity, and investigator-assessed relatedness statistically important. The registry separately reports serious and other adverse-event counts, but those counts do not themselves answer the primary endpoint as defined.
The five sequential cohorts also illustrate why dose-cohort results should be read cautiously. A pattern of counts across dose groups can be useful descriptively, but nonrandomized cohort assignment does not support the same causal interpretation as a randomized comparison. Small cohort counts are also imprecise. Without inferential estimates or uncertainty intervals, apparent differences should not be treated as firm evidence of a dose relationship.
Statistical transparency matters alongside the event counts. The record states the primary safety population and the collection window, but it does not report the numerical primary endpoint result, a statistical analysis, handling of missing observations, or a multiplicity approach for the listed secondary outcomes. These absences limit what can be concluded from the posted information. They also show why clear reporting of denominators, relatedness, outcome results and analytic methods is essential when readers evaluate early-phase clinical evidence.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The record describes a nonrandomized sequential study without a control arm. That design limits causal comparisons among cohorts and does not support a direct estimate against another treatment or no treatment. The cohorts are small, and the counts can change substantially with the experience of a single participant. No inferential analyses or confidence intervals are reported in the registry record.
The central limitation for interpreting the primary endpoint is that its numerical result is not reported in the registry record. The available serious and other adverse-event counts do not specify whether events were treatment-emergent and investigator-assessed as related, which are central features of the primary endpoint. The serious-event terms and percentages also do not provide cohort-specific attribution in the information.
The cohort descriptions are truncated, so the full dosing schedules cannot be reconstructed from the registry record. The listed conditions encompass several tumor types, but the registry entries do not give disease-specific cohort sizes or outcome results. This limits interpretation of how representative the participants were across the listed conditions.
Results for biomarker reduction and clearance are not reported in the registry record. Missing-data methods, the statistical analysis plan, any interim analyses, and multiplicity procedures are also not reported. The stated all-enrolled analysis population does not explain whether observations were complete or how unavailable data were treated. Together, these limitations mean the record supports descriptive reading of the posted counts, but not a precise or comparative statistical assessment of the intervention.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors — NCT04853017.
- Registry record last updated 2025-09-05; status last verified 2025-08.
- Results first posted 2025-01-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT04853017 is a completed, first-in-human Phase 1 study of ELI-002 2P in minimal residual disease associated with KRAS- or NRAS-mutated pancreatic ductal adenocarcinoma or other solid tumors. It was nonrandomized, unmasked and sequential, with enrollment of 25 across five cohorts receiving different stated amounts of Amph-CpG-7909. The primary outcome concerned participants with treatment-emergent adverse events considered related to ELI-002, collected through 28 days after the last dose.
The registry lists cohort counts for serious and other adverse events, and 0 deaths in each cohort. It also lists biomarker reduction and clearance as secondary outcomes. The numerical primary-endpoint result and biomarker results, inferential analyses, uncertainty intervals, missing-data methods and multiplicity procedures are not reported in the registry record. The available cohort counts should therefore be read descriptively, not as a randomized or causal comparison.