Drug
Selective Estrogen Receptor Covalent Antagonist H3B-6545
CI-DRUG-00000544Explore in graph →NCIt C142980 CIViC
Regulatory
Approvals (0)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
Data not yet available
No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.
What CancerIndex knows
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Phase2 | Phase 2 | 0 | 0 | 0 | 2 | 0 | — | — | Aug 23, 2017 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — | — | Aug 23, 2017 |
ComputedclinicaltrialsProvenance
- Source
- clinicaltrials
- Layer
- derived (computed by CancerIndex)
Data updated 18 hours agoSource updated unknown
Curated evidence
Clinical evidence (2)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 40830892
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ESR1 Y537S1 | ||||||||
| Selective Estrogen Receptor Covalent Antagonist H3B-6545 | ||||||||
Clinical trials
Trials with this intervention (2)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04568902 | Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer | completed | Phase 1 | 33 | Eisai Co., Ltd.INDUSTRY | 1 | Oct 23, 2025 | clinicaltrials |
| NCT03250676 | Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer | completed |