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Trials
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

trialsTrialRecruiting

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

A phase 1/2 trial of Dalpiciclib and HRS-8080 in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.

Overview Connected6

Overview

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT06167694 by Shandong Suncadia Medicine Co., Ltd., with 146 participants planned, started 2023-12-20 and due to reach its primary completion in 2026-06. Interventions recorded: HRS-8080; Dalpiciclib Isethionate Tablets.

Setting

A Multicenter, Open Phase Ib/II Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With ER-positive, HER2-negative Unresectable or Metastatic Breast Cancer

Phase

Phase 1/2

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Registry

Started

2023-12-20

Enrolled

146 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

technologies

CDK4/6 inhibitors Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule CDK4/6 inhibitor

Dalpiciclib · Airuikang

Phase 3small molecule (structure undisclosed or not yet in PubChem)

companies

Jiangsu Hengrui Pharmaceuticals

Evidence strength24/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
146 enrolled+11
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT06167694

Data

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

CDK4/6 inhibitors
Small-molecule kinase inhibitors

Products

Dalpiciclib
HRS-8080

Companies

Jiangsu Hengrui Pharmaceuticals

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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