Asset profile
H3B-6545
Small molecule
Evidence outlook · no controlled comparison
NCT03250676 · Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer,...
The lead study is single-arm or otherwise uncontrolled, so it produced no formal comparison against a control. This tier describes the design, not an outcome.
NCT03250676: This was a non-randomized, open-label study with no placebo or active-control group; 151 participants received H3B-6545 across dose-escalation and dose-expansion cohorts. Its primary outcomes were descriptive, including radiologic objective response, and there was no formal controlled comparison to determine whether the primary endpoint was met.
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 60 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| H3B-6545: this drug | Phase 1/2 | Small molecule | Estrogen receptor alpha (covalent antagonist) | ||
| Abemaciclib (Verzenio) | Approved | Small molecule | CDK4 and CDK6 | ||
| Alpelisib (BYL719) | Approved | Small molecule | PI3K-alpha | ||
| Anastrozole | Approved | Small molecule | Aromatase | ||
| Capecitabine | Approved | Small molecule | Fluoropyrimidine (antimetabolite) | ||
| Capivasertib | Approved | Small molecule | AKT (inhibitor) | ||
| Datopotamab Deruxtecan | Approved | Antibody–drug conjugate | TROP2 | ||
| Denosumab | Approved | Monoclonal antibody | RANKL | ||
| Docetaxel | Approved | Small molecule | Microtubules (tubulin) | ||
| Elacestrant | Approved | Small molecule | Estrogen receptor | ||
| Eribulin Mesylate | Approved | Small molecule | Tubulin / microtubules | ||
| Everolimus | Approved | Small molecule | mTOR kinase, mTOR (mTORC1) (inhibitor) | ||
| Exemestane | Approved | Small molecule | Aromatase | ||
| Fulvestrant (Faslodex) | Approved | Small molecule | Estrogen receptor | ||
| Gedatolisib | Approved | Small molecule | PI3K (class I isoforms) and mTORC1/mTORC2 | ||
| Gemcitabine | Approved | Small molecule | ribonucleotide reductase / DNA polymerase (dCTP competition) |
…and 45 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
No upcoming readouts on record for this asset.
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.