{"entity":{"id":"gim-531","kind":"drug","name":"GIM-531","aka":[],"tldr":"GIM-531 is an experimental oral small molecule from Georgiamune, in phase 1 trials for advanced solid tumours and stage IV melanoma.","summary":"GIM-531 is an oral small molecule from Georgiamune. A first-in-class oral small molecule that selectively inhibits the induction and function of regulatory T cells (Tregs), sparing other immune cells, to let the immune system attack the tumour. Its furthest stage is phase 1, for advanced solid tumours and stage IV melanoma. ClinicalTrials.gov registers it in one study linked below. First patient dosed July 2024; phase 1/2 alone and with anti-PD-1, recruiting (NCT06425926). Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"Georgiamune: georgiamune.com","url":"https://www.georgiamune.com/pipeline"},{"label":"Georgiamune: georgiamune.com","url":"https://www.georgiamune.com/news"},{"label":"Georgiamune: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT06425926"},{"label":"ClinicalTrials.gov: trials of GIM-531","url":"https://clinicaltrials.gov/search?intr=GIM-531"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["georgiamune"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06425926"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"GIM-531","modality":"Oral small molecule","mechanism":"A first-in-class oral small molecule that selectively inhibits the induction and function of regulatory T cells (Tregs), sparing other immune cells, to let the immune system attack the tumour.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gim-531/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"company":[{"id":"georgiamune","kind":"company","name":"Georgiamune","route":"/companies/georgiamune/"}],"trial":[{"id":"nct06425926","kind":"trial","name":"Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors","route":"/trials/nct06425926/"}]}}