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A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189717
Recruitment Status : Enrolling by invitation
First Posted : January 12, 2022
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Shandong Suncadia Medicine Co., Ltd.

Brief Summary:
The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic or Local Advanced Breast Cancer of Patients Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: HRS-8080 tablets monotherapy and combined with other anti-cancer therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer
Actual Study Start Date : February 17, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Single Group
Firstly Dose Escalation and Dose Expansion of HRS-8080 monotherapy should be conducted. After RP2D and MTD of the HRS-8080 monotherapy were confirmed, Dose Escalation and Dose Extension of HRS-8080 in combination with other anti-cancer treatment would be completed, including SHR 6390, or Abemaciclib, or Everolimus.
Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
During HRS-8080 monotherapy period, the dose of HRS-8080 would be increasing. In the combination therapy period, HRS-8080 will be administered at flat dose of RP2D-1 and RP2D.




Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: up to 28 days ]
    The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus

  2. Recommended phase II dose [ Time Frame: up to 28 days ]
    The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus

  3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [ Time Frame: up to 30 days after the last dose ]
    Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  2. Tmax [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.

  3. AUC0-t [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  4. Cmax,ss [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  5. Tmax,ss [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  6. Cmin,ss [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  7. AUCss [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  8. Rac [ Time Frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period ]
    PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.

  9. ORR [ Time Frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months ]
    Objective Response Rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer

  10. BOR [ Time Frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months ]
    Best Overall Response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer

  11. DoR [ Time Frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months ]
    Duration of response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer

  12. DCR [ Time Frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months ]
    Disease control rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer

  13. PFS [ Time Frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months ]
    Progression-free survival, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ECOG performance status score: 0-1;
  2. Histopathologically documented local advanced or metastatic breast cancer ;
  3. Female of not childbearing potential must the related requirement;
  4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
  5. Adequate organ functions as defined;
  6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

  1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
  2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
  3. History of clinically significant cardiovascular or cerebrovascular diseases;
  4. The subject has one of many factors affecting oral drugs;
  5. Active infection or fever with unknown cause > 38.5 °C;
  6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
  7. Known history of allergy to study drug ingredients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189717


Locations
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China, Beijing
Fifth Medical Center of People's Liberation Army of China General Hospital
Beijing, Beijing, China, 100071
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Sponsors and Collaborators
Shandong Suncadia Medicine Co., Ltd.
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Responsible Party: Shandong Suncadia Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT05189717    
Other Study ID Numbers: HRS-8080-I-101
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs