What human clinical trials of ivermectin in cancer are registered and what dosing cohorts do they use?
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Executive summary
Two U.S.-registered trials testing ivermectin in cancer patients are identifiable in recent reporting: a Phase I/II study combining ivermectin with the PD‑1 agonist balstilimab for metastatic triple‑negative breast cancer (ClinicalTrials.gov identifier NCT05318469) and at least one National Cancer Institute–listed study (NCI‑2022‑02421) that references ivermectin in combination therapy [1] [2] [3]. Public records and reviews emphasize that formal dosing cohorts for these cancer trials are not clearly reported in available abstracts and registry summaries, while separate pharmacology and safety literature documents human ivermectin dosing ranges from standard antiparasitic regimens (150–400 µg/kg) to investigational high doses (up to ~2 mg/kg) used in safety studies [4] [5] [6].
1. Registered trials: who and what is listed
ClinicalTrials.gov lists a Phase I/II trial NCT05318469 evaluating ivermectin combined with balstilimab in patients with metastatic triple‑negative breast cancer, a study presented as an ASCO abstract led by investigators at City of Hope and registered with Gateway for Cancer Research support [1] [7] [8]. Independent reporting and an integrative oncology summary assert that two U.S. trials of ivermectin in cancer were found on ClinicalTrials.gov, though only the NCT05318469 record is readily citable in the excerpts provided [3]. The NCI clinical trials listing references an ivermectin combination trial (NCI‑2022‑02421), signaling federal involvement or oversight in at least one study arm, but public excerpts do not include detailed protocol elements [2].
2. What the registries and abstracts say about dosing (and what they don't)
The ASCO meeting abstract and registry entries cited in these sources position the studies as Phase I safety/dose‑finding efforts or Phase I/II combination efficacy trials, but neither the abstract snippets nor the ClinicalTrials.gov summary in the provided material publish explicit dosing cohorts or escalation schemas for ivermectin in cancer patients [7] [1] [8]. Multiple reviews and literature searches highlighted in the reporting stress a recurring problem: clinical trial literature for ivermectin in oncology is scarce and often omits detailed human dosing in public summaries, which limits transparency about planned exposure levels in patients [6] [9].
3. Context from human pharmacology and safety literature that informs likely dose ranges
Independent human pharmacokinetic and safety studies provide context for what investigators might consider: routine antiparasitic ivermectin dosing in humans is 150–200 µg/kg (with higher 400 µg/kg regimens for some indications), isolated clinical research has escalated single or repeated doses in volunteers up to ~2 mg/kg without serious immediate adverse events, and a prior trial administered 1.6 mg/kg subcutaneously twice weekly in a different clinical context [4] [5]. These published human dose ranges are cited by authors arguing that concentrations producing anticancer effects in vitro may be reachable in vivo, but those assessments remain theoretical until oncology trials disclose their cohort schedules and pharmacokinetic targets [4] [5].
4. Competing narratives, gaps, and the risk of extrapolation
Advocacy sites and case‑report compilations trumpet high‑dose off‑label regimens and anecdotal patient successes—examples include self‑reported protocols reaching 1.5 mg/kg/day in combination regimens—yet these reports are not clinical trials and carry publication and selection biases that registry entries do not validate [10]. Peer‑reviewed reviews and systematic perspectives caution against extrapolating lab‑level efficacy to patients without randomized studies and note the absence of large RCT evidence for anticancer benefit [6] [9]. Given the registry silence on explicit cohort dosing in the cancer trials cited and the heterogeneity of non‑trial dosing reports, the responsible conclusion is that registered oncology trials exist but their ivermectin dosing cohorts are not publicly documented in the sources provided, and published human safety literature only suggests plausible dose ceilings for investigational use [1] [7] [5] [4].