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Recruiting NCT07389733

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

Phase I / Phase II Interventional Advanced Unresectable or Metastatic Breast Cancer of Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-6208 Capsule, HRS-6209 Capsule, HRS-8080 Tablet, Fulvestrant injection.
Who it may be relevant to
Registry conditions: Advanced Unresectable or Metastatic Breast Cancer of Adults. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study

Overview

This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.

Interventions

  • Drug HRS-6208 Capsule
    HRS-6208 capsule.
  • Drug HRS-6209 Capsule
    HRS-6209 capsule.
  • Drug HRS-8080 Tablet
    HRS-8080 tablet.
  • Drug Fulvestrant injection
    Fulvestrant injection.
  • Drug Letrozole tablets
    Letrozole tablets.

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.]
  • Recommended phase II dose (RP2D) [Time frame: The evaluation of RP2D will be completed approximately one year later than DLT evaluation.]
  • Incidence and severity of adverse events (AEs) [Time frame: Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.]
  • Objective response rate (ORR) [Time frame: For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.]
Secondary outcome measures (8)
  • Disease control rate (DCR) [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • Duration of response (DoR) [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • Progression-free survival (PFS) [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • Overall survival (OS) [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • The blood drug concentration of HRS-6208 [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • The blood drug concentration of HRS-8080 [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • The blood drug concentration of HRS-6209 [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]
  • The blood drug concentration of Letrozole [Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.]

Eligibility criteria

Inclusion criteria

  • Female, aged 18-75 (inclusive);
  • ECOG score 0-1;
  • Estimated survival time ≥ 12 weeks;
  • Possessing adequate bone marrow and organ function;
  • Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2 years after the last use of the trial medication;
  • Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.

Exclusion criteria

  • Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma;
  • Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;
  • Severe bone damage caused by tumor bone metastasis as determined by the investigator;
  • Adverse events caused by previous anti-tumor treatment have not been resolved;
  • Participants with one of multiple factors affecting oral medication;
  • History of severe cardiovascular and cerebrovascular diseases;
  • Presence of severe infections;
  • Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication;
  • Active autoimmune diseases, history of immune deficiency, history of autoimmune diseases, or history of diseases or syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or acquired conditions (HIV infection), congenital immune deficiency diseases, or history of organ transplantation;
  • Active untreated hepatitis;
  • History of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without standard treatment;
  • Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication;
  • Prior use of prohibited drugs specified in the protocol;
  • Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication;
  • History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction;
  • Allergic reactions to any study drug or excipients;
  • Factors confirmed by the investigator as unsuitable for participation in this clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Second Affiliated Hospital of Dalian Medical University — Dalian
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT07389733 · HRS-6208-201-BC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗