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Trial record 1 of 1 for:    CYH33-G103 | Breast Cancer
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Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856371
Recruitment Status : Not yet recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Haihe Biopharma Co., Ltd.

Brief Summary:
This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Patients will be enrolled in two stages, including dose exploration phase (Stage 1) and dose expansion phase (Stage 2) of each cohort.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: CYH33 Drug: Fulvestrant Drug: Letrozole Drug: Palbociclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: CYH33 + fulvestrant
Participants will receive CYH33 in combination with a standard fixed dose of fulvestrant 500 mg.
Drug: CYH33
Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.

Drug: Fulvestrant
Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1, 15 on Cycle 1 (28-day cycle) and Day 1 at each 28-day cycle thereafter.

Experimental: CYH33 + fulvestrant + palbociclib
Participants will receive CYH33 in combination with standard fixed dose of fulvestrant (500 mg) and palbociclib (125 mg).
Drug: CYH33
Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.

Drug: Fulvestrant
Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1, 15 on Cycle 1 (28-day cycle) and Day 1 at each 28-day cycle thereafter.

Drug: Palbociclib
Participants will receive palbociclib once daily continuous on Day 1-21 of each 28-day cycle.

Experimental: CYH33 + letrozole + palbociclib
Participants will receive CYH33 in combination with standard fixed dose of letrozole (2.5 mg) and palbociclib (125 mg)
Drug: CYH33
Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.

Drug: Letrozole
Participants will receive oral letrozole once daily continuous on Day 1-28 of each cycle.

Drug: Palbociclib
Participants will receive palbociclib once daily continuous on Day 1-21 of each 28-day cycle.




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]
    Incidence rate of DLT in the first cycle (of 28 days).


Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 30 months ]
    Type, incidence, duration, severity and seriousness of adverse events (AEs).

  2. Preliminary efficacy-ORR [ Time Frame: 30 months ]
    Tumor objective response rate (ORR) assessed by RECIST v1.1

  3. Preliminary efficacy-CBR [ Time Frame: 30 months ]
    Clinical benefit rate (CBR) assessed by RECIST v1.1

  4. Preliminary efficacy-PFS [ Time Frame: 30 months ]
    Progression Free Survival (PFS) assessed by RECIST v1.1

  5. Pharmacokinetic measures - AUC [ Time Frame: 20 months ]
    Measure the variation of concentration in blood plasma as a function of time

  6. Pharmacokinetic measures - C trough [ Time Frame: 20 months ]
    Measure the minimum (trough) plasma concentration

  7. Pharmacokinetic measures - Cmax [ Time Frame: 20 months ]
    Measure the maximum (peak) plasma concentration

  8. Pharmacokinetic measures - Tmax [ Time Frame: 20 months ]
    Measure of time to reach maximum (peak) plasma concentration

  9. Pharmacokinetic measures - CL/F [ Time Frame: 20 months ]
    Measure apparent total clearance(s) from plasma after administration

  10. Pharmacokinetic measures - Vz/F [ Time Frame: 20 months ]
    Measure apparent volume of distribution during terminal phase

  11. Assess downstream effects of PI3K pathway inhibition on blood glucose [ Time Frame: 20 months ]
    Pre- and post-treatment of blood glucose

  12. Assess downstream effects of PI3K pathway inhibition on C peptide [ Time Frame: 20 months ]
    Pre- and post-treatment of C peptide

  13. Assess the changes of biomarker-PIK3CA [ Time Frame: 20 months ]
    Pre- and post-treatment PIK3CA changes in ctDNA samples.

  14. Assess the changes of biomarker-PTEN [ Time Frame: 20 months ]
    Pre- and post-treatment PTEN changes in ctDNA samples.

  15. Assess the changes of biomarker-KRAS [ Time Frame: 20 months ]
    Pre- and post-treatment KRAS changes in ctDNA samples.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Provide informed consent voluntarily.
  2. Male and female patients ≥ 18 years of age.
  3. Patient must have a histologically or cytologically documented locally advanced, recurrent or metastatic breast cancer.
  4. In case of women, both premenopausal and postmenopausal patients can be enrolled in the study.
  5. Confirmed diagnosis of HR+, HER2- breast cancer.
  6. For Stage 1 dose exploration phase, patients with or without PIK3CA mutation may be enrolled; For Stage 2 dose expansion phase, patients with PIK3CA mutations are required.
  7. Patient must have evidence of disease radiological progression after previous endocrine therapy, or other systemic therapy.
  8. Patient has measurable disease per RECIST v1.1.
  9. ECOG ≤ 1.
  10. Patient must have adequate organ and bone marrow function.

Main Exclusion Criteria:

  1. Previously received any anticancer therapy within 28 days or 5 times of half-lives prior to the first dose of the study treatment.
  2. Previously received treatment with any PI3Kα inhibitor, AKT inhibitor, or mTOR inhibitor.
  3. Radical radiation therapy within 4 weeks prior to the first dose of the study treatment.
  4. Patient with an established diagnosis of diabetes mellitus.
  5. Any other concurrent disease with potential risk of insulin resistance or current use of medication with potential risk of insulin resistance.
  6. Patient with clinically significant cardiovascular disease.

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): NCT04856371


Contacts
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Contact: Yong Yuan, MD 86 13820384005 yong.yuan@haihepharma.com

Sponsors and Collaborators
Haihe Biopharma Co., Ltd.
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Responsible Party: Haihe Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04856371    
Other Study ID Numbers: CYH33-G103
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haihe Biopharma Co., Ltd.:
PIK3CA Mutant
Advanced Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Fulvestrant
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Protein Kinase Inhibitors