What published results exist from NCT05318469 (ivermectin + balstilimab) regarding safety and pharmacokinetics?

1. What the sponsors registered and where results would appear

The trial is registered as NCT05318469 on ClinicalTrials.gov and related trial listings, which provide protocol details but do not themselves host peer‑reviewed results in the materials supplied here ^{[3] [4] [5]}; therefore published outcome claims are found in meeting abstracts and trial‑network pages rather than an indexed full journal article in the provided reporting ^{[6] [7]}.

2. Conference abstracts reporting safety and early efficacy signals

An abstract published via the Journal of Clinical Oncology (ASCO supplement) reports the Phase I/II data and concludes the ivermectin + balstilimab combination was “safe and well tolerated,” and notes a 4‑month clinical benefit rate of 37.5% (95% CI 15.3%–91.7%) in the cohort described, with overall survival still too immature for analysis ^{[1] [2]}. An American Association for Cancer Research (AACR) abstract for the San Antonio Breast Cancer Symposium also documents an early phase I evaluation of the same combination, citing the trial identifier NCT05318469 and listing investigator authors consistent with the ASCO abstract ^[8].

3. What “safety” means in the available reports and their limits

The safety claim—“safe and well tolerated”—comes from the ASCO/JCO abstract summary but the supplied materials do not include the adverse event (AE) tables, dose‑limiting toxicity details, or numbers of patients exposed at each dose level that would normally underpin a robust safety assessment; therefore the assertion is limited to the abstract’s summary language rather than a full, adjudicated safety dataset available for independent review in the provided sources ^{[1] [2]}.

4. Pharmacokinetics: absence of trial PK data in the public abstracts

None of the provided sources present trial‑specific PK results (Cmax, AUC, clearance, or exposure‑response relationships) for ivermectin or balstilimab from NCT05318469; clinicaltrials.gov entries and meeting abstracts referenced here do not include detailed PK tables, so there is no published PK dataset from this study in the materials supplied ^{[3] [4] [1] [8]}.

5. Dosing schedule and mechanistic rationale as context

Trial listings and synopsis pages describe the dosing regimen used in the study—ivermectin given orally on days 1–3, 8–10, and 15–17 of each 21‑day cycle with balstilimab 300 mg IV on day 1—information that clarifies exposure timing but is not a substitute for measured PK values ^{[9] [10]}. Preclinical rationales for adding ivermectin (repurposing antiparasitic drug for immune potentiation/anticancer effects) are cited in trial descriptions and sponsor materials as the basis for the combination study ^{[6] [11]}.

6. Where the evidence stands and what is missing

The highest‑quality published evidence located in the supplied reporting is limited to conference abstracts concluding tolerability and early clinical benefit signals, but there is no publicly available, peer‑reviewed full article or trial registry result posting that provides detailed safety tables or pharmacokinetic analyses for NCT05318469 in these sources ^{[1] [2] [8] [3]}. Any definitive statements about PK—such as plasma Cmax, AUC, dose proportionality, or exposure‑toxicity relations—cannot be made from the materials provided; the reporting simply does not contain those data ^{[3] [4] [1]}.

7. Alternative interpretations and agendas to watch

Conference abstracts often present encouraging topline language that precedes full data disclosure; sponsors and advocacy pages emphasize potential and tolerability ^{[6] [11]} while independent evaluators will require full safety tables and PK reports to validate claims—readers should note the difference between abstract conclusions and comprehensive published datasets and be alert to promotional framing on trial‑network pages versus the scant technical detail in the meeting supplements ^{[6] [9]}.