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HRS-8080; Dalpiciclib Isethionate

Phase 1

Unresectable or Metastatic Breast Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 9, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06167694Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast CancerPHASE1 RECRUITING 146 — — Dec 20, 2023Jun 1, 2026Jan 9, 20262 China
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Study Endpoints
Primary Endpoints
Dose-limiting toxicity (DLT)
About 2 years
Maximum tolerated dose (MTD)
About 2 years
Recommended phase II dose (RP2D)
About 2 years
Safety endpoints: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
About 2 years
Outcome endpoint: Objective Response Rate (ORR)
About 2 years
Secondary Endpoints
Steady-state peak concentration (Cmax,ss)
About 2 years
Steady-state peak time (Tmax,ss)
About 2 years
Steady-state valley concentration (Cmin,ss)
About 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment group AEXPERIMENTAL -
Interventions
NameTypeDescription
HRS-8080; Dalpiciclib Isethionate TabletsDRUGHRS-8080 combined with Dalpiciclib Isethionate Tablets
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Eligibility Criteria
Age Range18 Years — 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Women aged 18-75 years with both ends included. 2. ECOG Physical status 0-1 points. 3. Patients with histologically confirmed metastatic or locally advanced breast cancer. 4. Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression ...

Countries:China
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