{"entity":{"id":"sph4336","kind":"drug","name":"SPH4336","aka":[],"tldr":"SPH4336 is an experimental small-molecule drug from Shanghai Pharmaceuticals in phase 3 trials for HR-positive / HER2-negative breast cancer, with its target not yet stated publicly.","summary":"SPH4336 is a small-molecule drug developed by Shanghai Pharmaceuticals. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral. It is the investigational product in 4 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT05744687 (Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer) and NCT05860465 (Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer), in HR-positive / HER2-negative breast cancer. The largest, NCT05744687, plans to enrol 374 participants with primary completion was scheduled for 2026-05-31 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of SPH4336","url":"https://clinicaltrials.gov/search?intr=SPH4336"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05744687","nct05860465","nct05944224","nct05872347"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"small molecule","mechanism":"Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/sph4336/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"company":[{"id":"shanghai-pharmaceuticals","kind":"company","name":"Shanghai Pharmaceuticals","route":"/companies/shanghai-pharmaceuticals/"}],"trial":[{"id":"nct05944224","kind":"trial","name":"A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.","route":"/trials/nct05944224/"},{"id":"nct05872347","kind":"trial","name":"Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.","route":"/trials/nct05872347/"},{"id":"nct05744687","kind":"trial","name":"Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer","route":"/trials/nct05744687/"},{"id":"nct05860465","kind":"trial","name":"Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer","route":"/trials/nct05860465/"}]}}