To Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects With HR-Positive/HER2-Negative Solid Tumor

NCT07358377 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-6209-205
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),

  To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer

  Screening up to study completion,, an average of 1 year.

Secondary Outcomes (7)

• Concentration

  From administration to C2, up to 4 months.

• Cmax,ss

  From administration to C2, up to 4 months.

• Cmin,ss

  From administration to C2, up to 4 months.

• Objective Response Rate (ORR)

  Screening up to study completion, an average of 2 years.

• Best of Response (DoR)

  Screening up to study completion, an average of 2 years.

Study Arms (1)

HRS-6209 Capsules and fulvestrant injection

EXPERIMENTAL

Drug: HRS-6209 Capsules and fulvestrant injection

Interventions

HRS-6209 Capsules and fulvestrant injection DRUG

HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection

HRS-6209 Capsules and fulvestrant injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
• Adequate bone marrow and other vital organ functions
• Adequate liver function tests
• HR-positive or HER2-negative solid tumor patients

You may not qualify if:

• Plan to receive any other anti-tumor therapy during the study.
• Active brain metastases .
• Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
• Previous use of fulvestrant
• clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
• With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
• With acute or active tuberculosis infection requiring medication.
• Pregnant or lactating women, or females planning to become pregnant During the study.
• 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

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Kathy You

CONTACT

+61 02 9299 0433; kathyyou@atridia.com

Ravi Patel

CONTACT

+61 452 363 506; ravi.patel@atridia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 22, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01