HRS-8080
HRS-8080 is an experimental small-molecule drug from Shandong Suncadia Medicine in phase 3 trials for HR-positive / HER2-negative breast cancer, with its target not yet stated publicly.
Overview
HRS-8080 is a small-molecule drug developed by Shandong Suncadia Medicine. 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: * HRS-8080 Tablet * Dalpiciclib Isethionate. It is the investigational product in 5 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07354022 (A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy), NCT07024173 (A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer) and NCT07349069 (A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer), in HR-positive / HER2-negative breast cancer. The largest, NCT07349069, plans to enrol 5500 participants with primary completion expected 2030-12. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas · Lines of therapy.
Trials
topTrials recruiting now
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Landmark trials
Latest papers
topQuery for this drug: (TITLE:"HRS-8080" OR ABSTRACT:"HRS-8080") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about HRS-8080, not a curated reading list.
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