{"entity":{"id":"bh-30643","kind":"drug","name":"BH-30643","aka":["OMNI-EGFR inhibitor"],"tldr":"BH-30643 is an experimental small molecule from BlossomHill Therapeutics, in phase 1 trials for EGFR-mutant non-small cell lung cancer and HER2-mutant non-small cell lung cancer.","summary":"BH-30643 (OMNI-EGFR inhibitor) is a small molecule (oral, non-covalent, macrocyclic) from BlossomHill Therapeutics. An orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective EGFR inhibitor designed to overcome the limitations of currently approved EGFR inhibitors, with selectivity over wild-type EGFR. Its furthest stage is phase 1, for EGFR-mutant non-small cell lung cancer and HER2-mutant non-small cell lung cancer. ClinicalTrials.gov registers it in one study linked below. Company pipeline shows Phase 1; the SOLARA registry entry is phase 1/2, recruiting. Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"BlossomHill Therapeutics: bhtherapeutics.com","url":"https://www.bhtherapeutics.com/pipeline"},{"label":"BlossomHill Therapeutics: bhtherapeutics.com","url":"https://www.bhtherapeutics.com/pipeline"},{"label":"BlossomHill Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT06706076"},{"label":"ClinicalTrials.gov: trials of BH-30643","url":"https://clinicaltrials.gov/search?intr=BH-30643"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["blossomhill-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06706076"],"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":"BH-30643","modality":"Small molecule (oral, non-covalent, macrocyclic)","mechanism":"An orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective EGFR inhibitor designed to overcome the limitations of currently approved EGFR inhibitors, with selectivity over wild-type EGFR.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/bh-30643/","neighbours":{"cancer":[{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"blossomhill-therapeutics","kind":"company","name":"BlossomHill Therapeutics","route":"/companies/blossomhill-therapeutics/"}],"trial":[{"id":"nct06706076","kind":"trial","name":"A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations","route":"/trials/nct06706076/"}]}}