Clinical trial · Interventional
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
An Open-Label, Multi-Center Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant or Letrozole in Patients With Solid Tumor
NCT07358377CI-TRIAL-00121515recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-6209 Capsules and fulvestrant injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-6209 Capsules and fulvestrant injection
- interventionNames
- Drug: HRS-6209 Capsules and fulvestrant injection
Primary outcomes (1)
- measure
- Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),
- timeFrame
- Screening up to study completion,, an average of 1 year.
- description
- To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer
Secondary outcomes (7)
- measure
- Concentration
- timeFrame
- From administration to Cycle2 , up to 4 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. Adequate bone marrow and other vital organ functions 3. Adequate liver function tests 4. HR-positive or HER2-negative solid tumor patients Exclusion Criteria 1. Plan to receive any other anti-tumor therapy during the study. 2. Active brain metastases . 3. Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure. 4. Previous use of fulvestrant 5. clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding. 6. With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease). 7. With acute or active tuberculosis infection requiring medication. 8. Pregnant or lactating women, or females planning to become pregnant During the study. 9. Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\] positive
References
Publications (0)
Data not yet available
No reference posted for this study.